https://neoplasm.org/api.php?action=feedcontributions&feedformat=atom&user=Qiangnai Neoplasm - User contributions [en] 2026-06-08T21:38:37Z User contributions MediaWiki 1.44.2 https://neoplasm.org/index.php?title=MediaWiki:Mobile.css&diff=209 MediaWiki:Mobile.css 2026-01-03T14:12:04Z <p>Qiangnai: </p> <hr /> <div>/* Left-align the &quot;Update&quot; banner and any similar top notices on mobile */<br /> .mw-notification, <br /> .sitenotice, <br /> .mw-content-ltr .postedit-container,<br /> div[style*=&quot;text-align:center&quot;],<br /> div[style*=&quot;text-align: center&quot;] {<br /> text-align: left !important;<br /> }<br /> <br /> /* Specifically target your custom banner if you used one */<br /> div[style*=&quot;background:#f0f8ff&quot;],<br /> div[style*=&quot;background:#fff3cd&quot;],<br /> div[style*=&quot;background:#e6f9e6&quot;] {<br /> text-align: left !important;<br /> }<br /> <br /> /* Optional: Add some left padding for better readability */<br /> .mw-notification,<br /> .sitenotice,<br /> div[style*=&quot;padding:1em&quot;] {<br /> padding-left: 1em !important;<br /> padding-right: 1em !important;<br /> }<br /> <br /> /* Enlarge site title &quot;Neoplasm&quot; next to logo – larger version */<br /> .mw-header .mw-wiki-title,<br /> .vector-header .mw-wiki-title,<br /> .header .mw-wiki-title a,<br /> .mw-logo-wordmark,<br /> #p-logo a span,<br /> #mw-header-container a {<br /> font-size: 2.4em !important; /* Adjust slightly: try 2.3em or 2.5em if needed */<br /> font-weight: bold !important;<br /> color: #002366 !important; /* Dark blue to match your theme */<br /> line-height: 1 !important;<br /> margin-left: 0.6rem !important; /* Spacing from logo */<br /> display: block !important;<br /> }<br /> <br /> /* Ensure header aligns logo and title properly */<br /> .mw-header,<br /> .vector-header,<br /> .header-container {<br /> display: flex !important;<br /> align-items: center !important;<br /> padding: 0.8rem 0 !important;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=208 MediaWiki:Common.css 2026-01-03T14:10:25Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }<br /> <br /> <br /> #mw-panel .portal h3 .mw-portlet-body-toggle,<br /> a[title=&quot;Hide&quot;] { /* Or the exact class for the hide link */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed !important;<br /> top: 0;<br /> height: 100vh;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }<br /> <br /> /* Bold the custom sidebar section headings: Update and Index */<br /> #p-Update .vector-menu-heading,<br /> #p-Index .vector-menu-heading {<br /> font-weight: bold !important;<br /> font-size: 1.05em; /* optional: keep consistent with your existing heading size */<br /> }<br /> <br /> /* Enlarge site title &quot;Neoplasm&quot; next to logo – larger version */<br /> .mw-header .mw-wiki-title,<br /> .vector-header .mw-wiki-title,<br /> .header .mw-wiki-title a,<br /> .mw-logo-wordmark,<br /> #p-logo a span,<br /> #mw-header-container a {<br /> font-size: 2.4em !important; /* Adjust slightly: try 2.3em or 2.5em if needed */<br /> font-weight: bold !important;<br /> color: #002366 !important; /* Dark blue to match your theme */<br /> line-height: 1 !important;<br /> margin-left: 0.6rem !important; /* Spacing from logo */<br /> display: block !important;<br /> }<br /> <br /> /* Ensure header aligns logo and title properly */<br /> .mw-header,<br /> .vector-header,<br /> .header-container {<br /> display: flex !important;<br /> align-items: center !important;<br /> padding: 0.8rem 0 !important;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=207 MediaWiki:Common.css 2026-01-03T14:08:40Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }<br /> <br /> <br /> #mw-panel .portal h3 .mw-portlet-body-toggle,<br /> a[title=&quot;Hide&quot;] { /* Or the exact class for the hide link */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed !important;<br /> top: 0;<br /> height: 100vh;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }<br /> <br /> /* Bold the custom sidebar section headings: Update and Index */<br /> #p-Update .vector-menu-heading,<br /> #p-Index .vector-menu-heading {<br /> font-weight: bold !important;<br /> font-size: 1.05em; /* optional: keep consistent with your existing heading size */<br /> }<br /> <br /> /* Enlarge site title &quot;Neoplasm&quot; to match the larger size */<br /> .vector-header .mw-page-title-main,<br /> #p-logo + a, /* fallback for some mobile/minerva elements */<br /> #site-title, /* additional safety */<br /> .mw-header .mw-wiki-title {<br /> font-size: 2.2em !important; /* core size for the large &quot;Neoplasm&quot; */<br /> font-weight: bold !important; /* makes it strong and authoritative */<br /> color: #003366 !important; /* dark blue to match your theme */<br /> line-height: 1.2 !important; /* tight vertical alignment with logo */<br /> margin-left: 0.8rem !important; /* spacing from the logo */<br /> }<br /> <br /> /* Optional: fine-tune vertical alignment with the logo */<br /> .vector-header {<br /> align-items: center;<br /> padding-top: 0.8rem;<br /> padding-bottom: 0.8rem;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=206 MediaWiki:Common.css 2026-01-03T14:03:01Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }<br /> <br /> <br /> #mw-panel .portal h3 .mw-portlet-body-toggle,<br /> a[title=&quot;Hide&quot;] { /* Or the exact class for the hide link */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed !important;<br /> top: 0;<br /> height: 100vh;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }<br /> <br /> /* Bold the custom sidebar section headings: Update and Index */<br /> #p-Update .vector-menu-heading,<br /> #p-Index .vector-menu-heading {<br /> font-weight: bold !important;<br /> font-size: 1.05em; /* optional: keep consistent with your existing heading size */<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=205 MediaWiki:Common.css 2026-01-03T13:46:07Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }<br /> <br /> <br /> #mw-panel .portal h3 .mw-portlet-body-toggle,<br /> a[title=&quot;Hide&quot;] { /* Or the exact class for the hide link */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed !important;<br /> top: 0;<br /> height: 100vh;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }<br /> <br /> /* Bold specific sidebar links */<br /> #n-update a,<br /> #n-index a {<br /> font-weight: bold !important;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Sidebar&diff=204 MediaWiki:Sidebar 2026-01-03T13:14:37Z <p>Qiangnai: </p> <hr /> <div>* Update<br /> ** FDA Oncology Approvals 2025|FDA Oncology Approvals 2025<br /> <br /> * Index<br /> ** mainpage|Main page<br /> ** Editorial Board|Editorial board<br /> ** Tutorial|Content tutorial<br /> ** https://redcap.link/hemoncreg|New user survey<br /> ** https://redcap.link/HemOnc.org|General feedback<br /> ** https://redcap.link/hemonc-sdc|Request a new regimen<br /> ** HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|Disclaimer<br /> <br /> * Data dashboard<br /> ** https://ccids.shinyapps.io/hemonc_dashboard/|Dashboard Shiny app<br /> <br /> * Top cancer pages<br /> ** Breast cancer|1. Breast cancer<br /> ** Multiple myeloma|2. Multiple myeloma<br /> ** Diffuse large B-cell lymphoma|3. DLBCL<br /> ** Non-small cell lung cancer |4. NSCLC<br /> ** Acute myeloid leukemia |5. AML<br /> ** Colorectal cancer|6. Colorectal cancer<br /> ** B-cell acute lymphoblastic leukemia |7. B-ALL<br /> ** Pancreatic cancer|8. Pancreatic cancer<br /> ** Head_and_neck_cancer|9. H &amp; N cancer<br /> ** Classical Hodgkin lymphoma|10. cHL<br /> <br /> * Reference pages<br /> ** Drug index|Drug index<br /> ** Vesicant &amp; irritant chemotherapy|Vesicants &amp; irritants<br /> ** Guidelines|Guidelines<br /> ** Antiemesis|Antiemetic support<br /> ** Performance status|Performance status<br /> ** ICD-10 &amp; ICD-9 codes|ICD billing codes<br /> ** Billing codes (CPT) and wRVUs|CPT E&amp;M billing codes<br /> ** Steroid conversions|Steroid conversions<br /> ** Consult topics in hematology and oncology|Consult topics<br /> ** Hematology Oncology Fellowship Programs Directory|Fellowship programs<br /> ** External links|External links<br /> ** Category:General reference pages|Full index of reference pages<br /> <br /> * Stay in touch<br /> ** http://www.facebook.com/HemOnc.org|Facebook<br /> ** https://www.linkedin.com/company/hemonc|LinkedIn<br /> ** Mailing list for HemOnc.org |Mailing list<br /> <br /> * How to contribute<br /> ** How to contribute|Read this first<br /> ** Help:Contents|Editing tutorial<br /> ** Style guide|Style guide<br /> ** Eligibility criteria|Inclusion criteria<br /> ** recentchanges-url|What's new<br /> <br /> * authoring<br /> ** Template:DiseasePage|New disease page (template)<br /> ** Help:Editing|How to edit pages<br /> <br /> * SEARCH<br /> * TOOLBOX</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Mobile.css&diff=201 MediaWiki:Mobile.css 2026-01-01T15:32:10Z <p>Qiangnai: Created page with &quot;/* Left-align the &quot;Update&quot; banner and any similar top notices on mobile */ .mw-notification, .sitenotice, .mw-content-ltr .postedit-container, div[style*=&quot;text-align:center&quot;], div[style*=&quot;text-align: center&quot;] { text-align: left !important; } /* Specifically target your custom banner if you used one */ div[style*=&quot;background:#f0f8ff&quot;], div[style*=&quot;background:#fff3cd&quot;], div[style*=&quot;background:#e6f9e6&quot;] { text-align: left !important; } /* Optional: Add some left...&quot;</p> <hr /> <div>/* Left-align the &quot;Update&quot; banner and any similar top notices on mobile */<br /> .mw-notification, <br /> .sitenotice, <br /> .mw-content-ltr .postedit-container,<br /> div[style*=&quot;text-align:center&quot;],<br /> div[style*=&quot;text-align: center&quot;] {<br /> text-align: left !important;<br /> }<br /> <br /> /* Specifically target your custom banner if you used one */<br /> div[style*=&quot;background:#f0f8ff&quot;],<br /> div[style*=&quot;background:#fff3cd&quot;],<br /> div[style*=&quot;background:#e6f9e6&quot;] {<br /> text-align: left !important;<br /> }<br /> <br /> /* Optional: Add some left padding for better readability */<br /> .mw-notification,<br /> .sitenotice,<br /> div[style*=&quot;padding:1em&quot;] {<br /> padding-left: 1em !important;<br /> padding-right: 1em !important;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Sitenotice&diff=200 MediaWiki:Sitenotice 2026-01-01T15:29:42Z <p>Qiangnai: Created page with &quot;&lt;div style=&quot;background:#f0f8ff; padding:1em; text-align:center; border-bottom:2px solid #007bff; font-weight:bold;&quot;&gt; &#039;&#039;&#039;Update&#039;&#039;&#039;: Latest oncology updates and approvals • FDA 2025 Approvals &lt;/div&gt;&quot;</p> <hr /> <div>&lt;div style=&quot;background:#f0f8ff; padding:1em; text-align:center; border-bottom:2px solid #007bff; font-weight:bold;&quot;&gt;<br /> '''Update''': [[Your_Update_Page_Title|Latest oncology updates and approvals]] • <br /> [[FDA_Oncology_Approvals_2025|FDA 2025 Approvals]]<br /> &lt;/div&gt;</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=199 MediaWiki:Common.css 2026-01-01T15:20:21Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }<br /> <br /> <br /> #mw-panel .portal h3 .mw-portlet-body-toggle,<br /> a[title=&quot;Hide&quot;] { /* Or the exact class for the hide link */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed !important;<br /> top: 0;<br /> height: 100vh;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=198 MediaWiki:Common.css 2026-01-01T15:18:37Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> <br /> /* Remove left margin/padding to push sidebar flush left */<br /> html, body {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> #mw-page-base, #mw-head-base, #mw-head, #content, #mw-panel {<br /> margin-left: 0 !important;<br /> padding-left: 0 !important;<br /> }<br /> <br /> /* Ensure the sidebar container has no offset */<br /> #mw-panel {<br /> left: 0 !important;<br /> position: absolute; /* Keeps it fixed in place */<br /> }<br /> <br /> /* Optional: Remove any inner padding in sidebar for tighter fit */<br /> #mw-panel .portal {<br /> padding-left: 0.5em; /* Adjust if text feels too close to edge */<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=197 MediaWiki:Common.css 2026-01-01T15:12:22Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=MediaWiki:Common.css&diff=196 MediaWiki:Common.css 2026-01-01T15:08:34Z <p>Qiangnai: </p> <hr /> <div>/* =========================================================<br /> Neoplasm / HemOnc – Global Site Styles (FINAL)<br /> ========================================================= */<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 0. Global font size<br /> --------------------------------------------------------- */<br /> body {<br /> font-size: 12px; /* change to 13–15px if you want larger overall text */<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 1. Hide Main Page title only<br /> --------------------------------------------------------- */<br /> .page-Main_Page h1.firstHeading {<br /> display: none;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 2. Typography helpers (Google-Docs–like editing)<br /> --------------------------------------------------------- */<br /> .neoplasm-center {<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-hero-subtitle {<br /> font-size: 1.15em;<br /> line-height: 1.55;<br /> max-width: 1100px;<br /> margin: 0 auto 24px auto;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 3. Main Page hero title (authoritative)<br /> Use this instead of styling .neoplasm-title directly,<br /> because VisualEditor may strip spans but keeps the wrapper div.<br /> --------------------------------------------------------- */<br /> .page-Main_Page .neoplasm-title-wrapper {<br /> display: block;<br /> width: 100%;<br /> text-align: center;<br /> margin: 1.2rem auto 1.6rem auto;<br /> <br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.9em;<br /> font-weight: 600;<br /> letter-spacing: 0.01em;<br /> color: #111;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 4. Optional: If you still use &lt;span class=&quot;neoplasm-title&quot;&gt; anywhere<br /> (kept consistent with the wrapper)<br /> --------------------------------------------------------- */<br /> .neoplasm-title {<br /> font-family: Georgia, &quot;Times New Roman&quot;, &quot;Nimbus Roman&quot;, &quot;Liberation Serif&quot;, serif;<br /> font-size: 1.5em; /* smaller than wrapper; adjust if needed */<br /> font-weight: 600;<br /> color: #003366;<br /> margin: 12px 0 20px 0;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 5. Base tables<br /> --------------------------------------------------------- */<br /> .neoplasm-table {<br /> width: 100%;<br /> text-align: center;<br /> font-weight: bold;<br /> border-collapse: collapse;<br /> font-size: 0.85em;<br /> }<br /> <br /> .neoplasm-table td,<br /> .neoplasm-table th {<br /> padding: 8px 10px;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 6. Quick links table (equal-width cells)<br /> --------------------------------------------------------- */<br /> .neoplasm-table--quicklinks {<br /> table-layout: fixed;<br /> width: 100%;<br /> }<br /> <br /> .neoplasm-table--quicklinks td {<br /> width: 20%; /* 5 equal columns */<br /> text-align: center;<br /> }<br /> <br /> .neoplasm-table-title {<br /> background-color: #737373;<br /> color: #ffffff;<br /> font-size: 1.3em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 7. Quick-link “chips”<br /> --------------------------------------------------------- */<br /> .neoplasm-chip {<br /> font-size: 1.1em;<br /> color: #ffffff;<br /> }<br /> <br /> .neoplasm-chip a,<br /> .neoplasm-chip a:visited {<br /> color: #ffffff;<br /> text-decoration: none;<br /> }<br /> <br /> .neoplasm-chip--solid { background-color: #08519c; }<br /> .neoplasm-chip--malignant { background-color: #cf0001; }<br /> .neoplasm-chip--peds { background-color: #ba871a; }<br /> .neoplasm-chip--tx { background-color: #4a1486; }<br /> .neoplasm-chip--classical { background-color: #31a354; }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 8. Disease section headers<br /> --------------------------------------------------------- */<br /> .neoplasm-major {<br /> color: #ffffff;<br /> font-size: 1.5em;<br /> }<br /> <br /> .neoplasm-major--solid { background-color: #08519c; }<br /> .neoplasm-major--heme { background-color: #cf0001; }<br /> .neoplasm-major--peds { background-color: #ba871a; }<br /> .neoplasm-major--tx { background-color: #4a1486; }<br /> .neoplasm-major--classical { background-color: #31a354; }<br /> <br /> .neoplasm-subheader {<br /> background-color: #bdd7e7;<br /> font-size: 1.2em;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 9. Standard table cells<br /> --------------------------------------------------------- */<br /> .neoplasm-cell {<br /> background-color: #eff3ff;<br /> }<br /> <br /> .neoplasm-cell--w25 {<br /> width: 25%;<br /> }<br /> <br /> <br /> /* ---------------------------------------------------------<br /> 10. Footer link<br /> --------------------------------------------------------- */<br /> .neoplasm-footer-link {<br /> text-align: center;<br /> font-size: 1.2em;<br /> margin-top: 24px;<br /> }<br /> <br /> <br /> /* =========================================================<br /> 11. Vector 2022 – Sidebar (FINAL SAFE VERSION)<br /> Keeps sidebar normal + collapsible, avoids blank white column.<br /> Also includes your spacing + font-size tweaks.<br /> ========================================================= */<br /> @media (min-width: 900px) {<br /> <br /> /* Keep hamburger icon visible */<br /> .skin-vector-2022 .vector-main-menu-dropdown {<br /> display: inline-flex;<br /> }<br /> <br /> /* Slightly tighter padding in sidebar */<br /> .skin-vector-2022 .vector-sidebar {<br /> padding-left: 0.5rem;<br /> padding-right: 0.75rem;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu {<br /> margin-left: 0;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content {<br /> padding-left: 0.25rem;<br /> }<br /> <br /> /* Sidebar heading + link sizing */<br /> .skin-vector-2022 .vector-menu-heading {<br /> font-size: 1.05em;<br /> }<br /> <br /> .skin-vector-2022 .vector-menu-content a {<br /> font-size: 1.0em;<br /> }<br /> }<br /> <br /> /* =========================================================<br /> End of file<br /> ========================================================= */<br /> /* Force dark blue in neoplasm tables EXCEPT the quick-links table */<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) td *,<br /> .neoplasm-table:not(.neoplasm-table--quicklinks) th * {<br /> color: #003366 !important;<br /> }<br /> <br /> .vector-pinnable-header--pinned .vector-pinnable-header-pin-button {<br /> display: none !important; /* Optional: hides the unpin button */<br /> }<br /> body.skin-vector .mw-page-container {<br /> margin-left: 240px !important; /* Adjust if needed for wider sidebar */<br /> }<br /> #vector-main-menu-pinned-container {<br /> display: block !important;<br /> }<br /> .vector-menu-tabs { /* Hides the TOC if you want sidebar priority */<br /> display: none !important;<br /> }<br /> <br /> #mw-panel {<br /> position: fixed;<br /> top: 0;<br /> height: 100%;<br /> overflow-y: auto;<br /> z-index: 10;<br /> }<br /> #content {<br /> margin-left: 240px; /* Adjust to match sidebar width */<br /> }</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=195 FDA Oncology Approvals 2025 2026-01-01T15:03:12Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW<br /> |-<br /> | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW<br /> |-<br /> | 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304<br /> |-<br /> | 16 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low Avutometinib + Defactinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201<br /> |-<br /> | 17 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY<br /> |-<br /> | 18 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016<br /> |-<br /> | 19 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303<br /> |-<br /> | 20 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE<br /> |-<br /> | 21 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive NSCLC || TRUST-II<br /> |-<br /> | 22 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck Pembrolizumab (Keytruda)] || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689<br /> |-<br /> | 23 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle Mitomycin intravesical solution (Zusduri)] || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 24 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND<br /> |-<br /> | 25 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05<br /> |-<br /> | 26 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 Sunvozertinib (Zegfrovy)] || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B<br /> |-<br /> | 27 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1<br /> |-<br /> | 28 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)<br /> |-<br /> | 29 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1<br /> |-<br /> | 30 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC with CIS || SunRISe-1<br /> |-<br /> | 31 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT<br /> |-<br /> | 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77<br /> |-<br /> | 33 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 34 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq)] || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte<br /> |-<br /> | 35 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST<br /> |-<br /> | 36 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8<br /> |-<br /> | 37 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || AUGMENT-101<br /> |-<br /> | 38 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 39 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001<br /> |-<br /> | 40 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies<br /> |-<br /> | 41 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1<br /> |-<br /> | 42 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform Selumetinib (Koselugo)] || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT<br /> |-<br /> | 43 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA<br /> |-<br /> | 44 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer Sevabertinib (Hyrnuo)] || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01<br /> |-<br /> | 45 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301<br /> |-<br /> | 46 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev)] || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303<br /> |-<br /> | 47 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN<br /> |-<br /> | 48 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN<br /> |-<br /> | 49 || 2025-12-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL<br /> |-<br /> | 50 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib + Abiraterone acetate (Akeega)] || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE<br /> |-<br /> | 51 || 2025-12-15 || [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab] || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09<br /> |-<br /> | 52 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer Rucaparib (Rubraca)] || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=194 FDA Oncology Approvals 2025 2026-01-01T15:00:26Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW<br /> |-<br /> | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW<br /> |-<br /> | 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304<br /> |-<br /> | 16 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low Avutometinib + Defactinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201<br /> |-<br /> | 17 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY<br /> |-<br /> | 18 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016<br /> |-<br /> | 19 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303<br /> |-<br /> | 20 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE<br /> |-<br /> | 21 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive NSCLC || TRUST-II<br /> |-<br /> | 22 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck Pembrolizumab (Keytruda)] || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689<br /> |-<br /> | 23 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle Mitomycin intravesical solution (Zusduri)] || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 24 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND<br /> |-<br /> | 25 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05<br /> |-<br /> | 26 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 Sunvozertinib (Zegfrovy)] || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B<br /> |-<br /> | 27 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1<br /> |-<br /> | 28 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)<br /> |-<br /> | 29 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1<br /> |-<br /> | 30 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC with CIS || SunRISe-1<br /> |-<br /> | 31 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT<br /> |-<br /> | 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77<br /> |-<br /> | 33 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 34 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq)] || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte<br /> |-<br /> | 35 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST<br /> |-<br /> | 36 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8<br /> |-<br /> | 37 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || AUGMENT-101<br /> |-<br /> | 38 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 39 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001<br /> |-<br /> | 40 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies<br /> |-<br /> | 41 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1<br /> |-<br /> | 42 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform Selumetinib (Koselugo)] || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT<br /> |-<br /> | 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA<br /> |-<br /> | 44 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer Sevabertinib (Hyrnuo)] || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01<br /> |-<br /> | 45 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301<br /> |-<br /> | 46 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev)] || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303<br /> |-<br /> | 47 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN<br /> |-<br /> | 48 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN<br /> |-<br /> | 49 || 2025-12-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL<br /> |-<br /> | 50 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib + Abiraterone acetate (Akeega)] || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE<br /> |-<br /> | 51 || 2025-12-15 || [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab] || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09<br /> |-<br /> | 52 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer Rucaparib (Rubraca)] || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=193 FDA Oncology Approvals 2025 2026-01-01T14:55:04Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW<br /> |-<br /> | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW<br /> |-<br /> | 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304<br /> |-<br /> | 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201<br /> |-<br /> | 17 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY<br /> |-<br /> | 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016<br /> |-<br /> | 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303<br /> |-<br /> | 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE<br /> |-<br /> | 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC || TRUST-II<br /> |-<br /> | 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689<br /> |-<br /> | 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND<br /> |-<br /> | 25 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05<br /> |-<br /> | 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B<br /> |-<br /> | 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1<br /> |-<br /> | 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)<br /> |-<br /> | 29 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1<br /> |-<br /> | 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS || SunRISe-1<br /> |-<br /> | 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT<br /> |-<br /> | 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77<br /> |-<br /> | 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte<br /> |-<br /> | 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST<br /> |-<br /> | 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8<br /> |-<br /> | 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || AUGMENT-101<br /> |-<br /> | 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001<br /> |-<br /> | 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies<br /> |-<br /> | 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1<br /> |-<br /> | 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT<br /> |-<br /> | 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA<br /> |-<br /> | 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01<br /> |-<br /> | 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301<br /> |-<br /> | 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303<br /> |-<br /> | 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN<br /> |-<br /> | 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN<br /> |-<br /> | 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL<br /> |-<br /> | 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE<br /> |-<br /> | 51 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09<br /> |-<br /> | 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3<br /> |-<br /> | 53 || 2025-12-17 || Rucaparib (Rubraca) || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=192 FDA Oncology Approvals 2025 2026-01-01T14:52:25Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW<br /> |-<br /> | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW<br /> |-<br /> | 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304<br /> |-<br /> | 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201<br /> |-<br /> | 17 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY<br /> |-<br /> | 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016<br /> |-<br /> | 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303<br /> |-<br /> | 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE<br /> |-<br /> | 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC || TRUST-II<br /> |-<br /> | 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689<br /> |-<br /> | 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND<br /> |-<br /> | 25 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05<br /> |-<br /> | 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B<br /> |-<br /> | 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1<br /> |-<br /> | 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)<br /> |-<br /> | 29 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1<br /> |-<br /> | 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS || SunRISe-1<br /> |-<br /> | 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT<br /> |-<br /> | 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications || <br /> |-<br /> | 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte<br /> |-<br /> | 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST<br /> |-<br /> | 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8<br /> |-<br /> | 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || AUGMENT-101<br /> |-<br /> | 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001<br /> |-<br /> | 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || <br /> |-<br /> | 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1<br /> |-<br /> | 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT<br /> |-<br /> | 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA<br /> |-<br /> | 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01<br /> |-<br /> | 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301<br /> |-<br /> | 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303<br /> |-<br /> | 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN<br /> |-<br /> | 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN<br /> |-<br /> | 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL<br /> |-<br /> | 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE<br /> |-<br /> | 51 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09<br /> |-<br /> | 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3<br /> |-<br /> | 53 || 2025-12-17 || Rucaparib (Rubraca) || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=191 FDA Oncology Approvals 2025 2026-01-01T14:49:14Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW<br /> |-<br /> | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW<br /> |-<br /> | 15 || 2025-04-23 || Penpulimab-kcqx || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304<br /> |-<br /> | 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201<br /> |-<br /> | 17 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY<br /> |-<br /> | 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016<br /> |-<br /> | 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303<br /> |-<br /> | 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE<br /> |-<br /> | 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC || TRUST-II<br /> |-<br /> | 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689<br /> |-<br /> | 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND<br /> |-<br /> | 25 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05<br /> |-<br /> | 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B<br /> |-<br /> | 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1<br /> |-<br /> | 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)<br /> |-<br /> | 29 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1<br /> |-<br /> | 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS || <br /> |-<br /> | 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT<br /> |-<br /> | 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications || <br /> |-<br /> | 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte<br /> |-<br /> | 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST<br /> |-<br /> | 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8<br /> |-<br /> | 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || AUGMENT-101<br /> |-<br /> | 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma || <br /> |-<br /> | 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001<br /> |-<br /> | 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || <br /> |-<br /> | 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1<br /> |-<br /> | 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT<br /> |-<br /> | 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA<br /> |-<br /> | 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01<br /> |-<br /> | 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301<br /> |-<br /> | 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303<br /> |-<br /> | 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN<br /> |-<br /> | 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN<br /> |-<br /> | 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL<br /> |-<br /> | 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE<br /> |-<br /> | 51 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09<br /> |-<br /> | 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3<br /> |-<br /> | 53 || 2025-12-17 || Rucaparib (Rubraca) || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=190 FDA Oncology Approvals 2025 2026-01-01T14:48:04Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || ReNeu<br /> |-<br /> | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=189 FDA Oncology Approvals 2025 2026-01-01T14:44:51Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || Acalabrutinib (Calquence) || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || <br /> |-<br /> | 2 || 2025-01-16 || Sotorasib (Lumakras) &lt;br /&gt; Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || <br /> |-<br /> | 3 || 2025-01-17 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || <br /> |-<br /> | 4 || 2025-01-21 || Treosulfan (Grafapex) || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || <br /> |-<br /> | 5 || 2025-01-27 || Fam-trastuzumab deruxtecan-nxki (Enhertu) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || <br /> |-<br /> | 6 || 2025-02-11 || Mirdametinib (Gomekli) || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult &amp; pediatric ≥2 years) || <br /> |-<br /> | 7 || 2025-02-12 || Brentuximab vedotin (Adcetris) || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || <br /> |-<br /> | 8 || 2025-02-14 || Vimseltinib (Romvimza) || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || <br /> |-<br /> | 9 || 2025-03-19 || Pembrolizumab (Keytruda) || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || <br /> |-<br /> | 10 || 2025-03-26 || Cabozantinib (Cabometyx) || Exelixis || Locally advanced or metastatic pNET and epNET (adult &amp; pediatric ≥12 years) || <br /> |-<br /> | 11 || 2025-03-28 || Durvalumab (Imfinzi) || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || <br /> |-<br /> | 12 || 2025-03-28 || Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || <br /> |-<br /> | 13 || 2025-04-08 || Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || <br /> |-<br /> | 14 || 2025-04-11 || Nivolumab (Opdivo) &lt;br /&gt; Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || <br /> |-<br /> | 15 || 2025-04-23 || Penpulimab-kcqx || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || <br /> |-<br /> | 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || <br /> |-<br /> | 17 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || NSCLC with high c-Met overexpression (accelerated) || <br /> |-<br /> | 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma || <br /> |-<br /> | 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || <br /> |-<br /> | 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || <br /> |-<br /> | 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC || <br /> |-<br /> | 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || <br /> |-<br /> | 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || <br /> |-<br /> | 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || <br /> |-<br /> | 25 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || <br /> |-<br /> | 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || <br /> |-<br /> | 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || <br /> |-<br /> | 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || <br /> |-<br /> | 29 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || <br /> |-<br /> | 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS || <br /> |-<br /> | 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || <br /> |-<br /> | 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications || <br /> |-<br /> | 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || <br /> |-<br /> | 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || <br /> |-<br /> | 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || <br /> |-<br /> | 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || <br /> |-<br /> | 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult &amp; pediatric ≥1 year) || <br /> |-<br /> | 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma || <br /> |-<br /> | 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || <br /> |-<br /> | 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || <br /> |-<br /> | 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || <br /> |-<br /> | 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || <br /> |-<br /> | 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || <br /> |-<br /> | 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || <br /> |-<br /> | 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) || <br /> |-<br /> | 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || <br /> |-<br /> | 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || <br /> |-<br /> | 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || <br /> |-<br /> | 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || <br /> |-<br /> | 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || <br /> |-<br /> | 51 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || <br /> |-<br /> | 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications || <br /> |-<br /> | 53 || 2025-12-17 || Rucaparib (Rubraca) || pharma&amp; GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || <br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=186 FDA Oncology Approvals 2025 2026-01-01T13:54:51Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=185 FDA Oncology Approvals 2025 2026-01-01T13:53:50Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=184 FDA Oncology Approvals 2025 2026-01-01T13:47:21Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=183 FDA Oncology Approvals 2025 2026-01-01T13:40:40Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=182 FDA Oncology Approvals 2025 2026-01-01T13:40:14Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=180 FDA Oncology Approvals 2025 2026-01-01T13:39:19Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=178 FDA Oncology Approvals 2025 2026-01-01T06:48:34Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor || MOTION<br /> |-<br /> | 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW<br /> |-<br /> | 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW<br /> |-<br /> | 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW<br /> |-<br /> | 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304<br /> |-<br /> | 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202<br /> |-<br /> | 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 19 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered thyroid and solid tumors || LIBRETTO-121<br /> |-<br /> | 20 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 21 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 26 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 27 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 29 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 31 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 35 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 36 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 37 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || SunRISe-1<br /> |-<br /> | 38 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic PN (1 year+) || SPRINT<br /> |-<br /> | 39 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 40 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 41 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 42 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 43 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 44 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 45 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 46 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A<br /> |-<br /> | 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1<br /> |-<br /> | 49 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-304<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=177 FDA Oncology Approvals 2025 2026-01-01T06:26:09Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=176 FDA Oncology Approvals 2025 2026-01-01T06:17:18Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=175 FDA Oncology Approvals 2025 2026-01-01T06:15:53Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=174 FDA Oncology Approvals 2025 2026-01-01T06:14:20Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=173 FDA Oncology Approvals 2025 2026-01-01T06:11:03Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=172 FDA Oncology Approvals 2025 2026-01-01T06:09:47Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> || 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=171 FDA Oncology Approvals 2025 2026-01-01T06:08:58Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> <br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=170 FDA Oncology Approvals 2025 2026-01-01T06:05:54Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A<br /> |-<br /> | 15 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A<br /> |-<br /> | 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high metastatic non-squamous NSCLC || LUMINOSITY<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 30 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 31 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 32 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1-positive NSCLC || TRUST-I<br /> |-<br /> | 33 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 35 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (FL) || inMIND<br /> |-<br /> | 36 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 37 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1<br /> |-<br /> | 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201<br /> |-<br /> | 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 42 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month formulation) || FP-001 LMIS<br /> |-<br /> | 43 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || N/A<br /> |-<br /> | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 45 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 46 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 47 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 48 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 49 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory multiple myeloma || DREAMM-7<br /> |-<br /> | 50 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 51 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=169 FDA Oncology Approvals 2025 2026-01-01T05:53:49Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> ! Item Number !! Approval Date !! Approval Type !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name !! FDA Approval Link<br /> |-<br /> | 1 || 12/17/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen Biotech, Inc. || subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection<br /> |-<br /> | 2 || 12/17/2025 || Regular approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer rucaparib (Rubraca)] || pharmaand GmbH || adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer<br /> |-<br /> | 3 || 12/15/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive-breast-cancer fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo, Inc. || the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive-breast-cancer<br /> |-<br /> | 4 || 12/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration-sensitive-prostate-cancer niraparib and abiraterone acetate (Akeega)] || Janssen Biotech, Inc. || adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration-sensitive-prostate-cancer<br /> |-<br /> | 5 || 12/4/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma lisocabtagene maraleucel (Breyanzi)] || Juno Therapeutics, Inc., a Bristol-Myers Squibb Company || adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma<br /> |-<br /> | 6 || 12/3/2025 || Traditional approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic pirtobrutinib (Jaypirca)] || Eli Lilly and Company || adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic<br /> |-<br /> | 7 || 11/25/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma durvalumab (Imfinzi)] || AstraZeneca || approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma<br /> |-<br /> | 8 || 11/21/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer pembrolizumab (Keytruda)] || Merck || approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer<br /> |-<br /> | 9 || 11/19/2025 || Traditional approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer tarlatamab-dlle (Imdelltra)] || Amgen Inc. || adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer<br /> |-<br /> | 10 || 11/19/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer sevabertinib (Hyrnuo)] || Bayer HealthCare Pharmaceuticals Inc. || adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer<br /> |-<br /> | 11 || 11/19/2025 || Traditional approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen Biotech Inc. || granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain<br /> |-<br /> | 12 || 11/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform selumetinib (KOSELUGO)] || AstraZeneca Pharmaceuticals LP || adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform<br /> |-<br /> | 13 || 11/18/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications epcoritamab-bysp (Epkinly)] || Genmab US, Inc. || approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL); also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications<br /> |-<br /> | 14 || 11/13/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Poherdy (pertuzumab-dpzb)] || Shanghai Henlius Biologics Co. Ltd. || an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta<br /> |-<br /> | 15 || 11/13/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation ziftomenib (Komzifti)] || Kura Oncology, Inc. || adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation<br /> |-<br /> | 16 || 11/6/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen Biotech, Inc. || adults with high-risk smoldering multiple myeloma (SMM) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma<br /> |-<br /> | 17 || 10/24/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation revumenib (Revuforj)] || Syndax Pharmaceuticals, Inc. || relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation<br /> |-<br /> | 18 || 10/23/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma belantamab mafodotin-blmf (Blenrep)] || GlaxoSmithKline || with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma<br /> |-<br /> | 19 || 10/8/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma cemiplimab-rwlc (Libtayo)] || Regeneron Pharmaceuticals Inc. || the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma<br /> |-<br /> | 20 || 10/2/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive lurbinectedin (Zepzelca)] || Jazz Pharmaceuticals, Inc. || in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive<br /> |-<br /> | 21 || 9/25/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast imlunestrant (Inluriyo)] || Eli Lilly and Company || adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast<br /> |-<br /> | 22 || 9/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection<br /> |-<br /> | 23 || 9/10/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 selumetinib (KOSELUGO)] || AstraZeneca Pharmaceuticals LP || granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1<br /> |-<br /> | 24 || 9/9/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer gemcitabine intravesical system (Inlexzo)] || Janssen Biotech, Inc. || adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer<br /> |-<br /> | 25 || 8/8/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations zongertinib (Hernexeos)] || Boehringer Ingelheim Pharmaceuticals, Inc. || adults with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations<br /> |-<br /> | 26 || 8/6/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma dordaviprone (Modeyso)] || Jazz Pharmaceuticals, Inc. || adults and pediatric patients 1 year and older with diffuse midline glioma (DMG) with H3 K27M mutation after progression following prior therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma<br /> |-<br /> | 27 || 7/2/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 sunvozertinib (Zegfrovy)] || Dizal (Jiangsu) Pharmaceutical Co., Ltd. || adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20<br /> |-<br /> | 28 || 7/2/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma linvoseltamab-gcpt (Lynozyfic)] || Regeneron Pharmaceuticals, Inc. || adult patients with relapsed or refractory multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma<br /> |-<br /> | 29 || 6/23/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo, Inc. || adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) whose disease has progressed on or after treatment with an EGFR-directed therapy and platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer<br /> |-<br /> | 30 || 6/18/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma tafasitamab-cxix (Monjuvi)] || Incyte Corporation || with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma<br /> |-<br /> | 31 || 6/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck pembrolizumab (Keytruda)] || Merck || adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck<br /> |-<br /> | 32 || 6/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle mitomycin intravesical solution (Zusduri)] || UroGen Pharma || adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle<br /> |-<br /> | 33 || 6/11/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer taletrectinib (Ibtrozi)] || Nuvation Bio Inc. || adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer<br /> |-<br /> | 34 || 6/3/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer darolutamide (Nubeqa)] || Bayer Healthcare Pharmaceuticals Inc. || adults with metastatic castration-sensitive prostate cancer (mCSPC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer<br /> |-<br /> | 35 || 5/15/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma retifanlimab-dlwr (Zynyz)] || Incyte Corporation || with carboplatin and paclitaxel for first-line treatment and as monotherapy for adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma<br /> |-<br /> | 36 || 5/14/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression telisotuzumab vedotin-tllv (Emrelis)] || AbbVie Inc. || adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression (IHC 3+) whose disease has progressed on or after systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression<br /> |-<br /> | 37 || 5/14/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma belzutifan (Welireg)] || Merck &amp; Co., Inc. || adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma<br /> |-<br /> | 38 || 5/8/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack)] || Verastem, Inc. || adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low<br /> |-<br /> | 39 || 4/23/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma penpulimab-kcqx] || Akeso Biopharma Co., Ltd. || adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma<br /> |-<br /> | 40 || 4/11/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma nivolumab (Opdivo)] || Bristol Myers Squibb Company || nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma<br /> |-<br /> | 41 || 4/8/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer nivolumab (Opdivo)] || Bristol Myers Squibb Company || nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer<br /> |-<br /> | 42 || 3/28/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer durvalumab (Imfinzi)] || AstraZeneca || durvalumab with gemcitabine and cisplatin as neoadjuvant treatment followed by durvalumab as adjuvant treatment after radical cystectomy for adults with muscle invasive bladder cancer (MIBC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer<br /> |-<br /> | 43 || 3/28/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication lutetium lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis Pharmaceuticals Corporation || adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication<br /> |-<br /> | 44 || 3/26/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet cabozantinib (Cabometyx)] || Exelixis, Inc. || adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet<br /> |-<br /> | 45 || 3/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma pembrolizumab (Keytruda)] || Merck || pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma<br /> |-<br /> | 46 || 2/14/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor vimseltinib (Romvimza)] || Deciphera Pharmaceuticals, LLC || adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor<br /> |-<br /> | 47 || 2/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell brentuximab vedotin (Adcetris)] || Seagen Inc. (subsidiary of Pfizer) || brentuximab vedotin with lenalidomide and rituximab for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy who are ineligible for autologous HSCT or CAR T-cell therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell<br /> |-<br /> | 48 || 2/11/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic mirdametinib (Gomekli)] || SpringWorks Therapeutics, Inc. || adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic<br /> |-<br /> | 49 || 2/6/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or treosulfan (Grafapex)] || medac GmbH || treosulfan with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or<br /> |-<br /> | 50 || 1/27/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo, Inc. || adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2<br /> |-<br /> | 51 || 1/17/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo, Inc. || adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast<br /> |-<br /> | 52 || 1/16/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer sotorasib (Lumakras)] || Amgen Inc. || adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer<br /> |-<br /> | 53 || 1/16/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma acalabrutinib (Calquence)] || AstraZeneca || adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=168 FDA Oncology Approvals 2025 2026-01-01T05:27:08Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or-mds Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2-ultralow-breast-cancer Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic-plexiform-neurofibromas-not-amenable-complete-resection Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell-lymphoma Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor || MOTION<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tevimbra Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-combination-cisplatin-and-gemcitabine-unresectable-or-metastatic-urothelial Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low-grade-serous-ovarian-cancer Avutometinib] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low-grade-serous-ovarian-cancer Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selpercatinib-pediatric-patients-two-years-and-older-ret-altered Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer / RET-fusion thyroid cancer / RET-fusion solid tumors || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma-anal-canal Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-for-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-for-recurrent-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20-insertion-mutations Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 37 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 38 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219745Orig1s000ltr.pdf Leuprolide mesylate (Camcevi ETM)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || Bridge<br /> |-<br /> | 41 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-who-have-symptomatic-inoperable-plexiform-neurofibromas Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 42 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 43 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 44 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive-stage-small-cell-lung-cancer Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 45 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 46 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 47 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 48 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic-lymphoma Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=167 FDA Oncology Approvals 2025 2026-01-01T05:20:58Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor || MOTION<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 37 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 38 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || Bridge<br /> |-<br /> | 41 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 42 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 43 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 44 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 45 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 46 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 47 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 48 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=166 FDA Oncology Approvals 2025 2026-01-01T05:19:19Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 4 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 6 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 7 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 9 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 11 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 12 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 14 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 15 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || Pre-taxane metastatic mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 18 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 20 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 21 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 23 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 26 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 27 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 29 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 30 || 2025-05-15 || || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line squamous cell anal carcinoma || POD1UM-303<br /> |-<br /> | 31 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 32 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 33 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I<br /> |-<br /> | 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 35 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 36 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 37 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 38 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 39 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 40 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 41 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201<br /> |-<br /> | 42 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 43 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 44 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || Bridge<br /> |-<br /> | 45 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT<br /> |-<br /> | 46 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475<br /> |-<br /> | 47 || 2025-09-25 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Imlunestrant (Inluriyo)] || Eli Lilly || ER+, HER2-, ESR1-mutated metastatic breast cancer || EMBER-3<br /> |-<br /> | 48 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || Maintenance for Extensive-stage SCLC || IMforte<br /> |-<br /> | 49 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant treatment for CSCC || C-POST<br /> |-<br /> | 50 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 51 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 52 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab (Rybrevant Faspro)] || Janssen || Subcutaneous NSCLC delivery (All indications) || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=165 FDA Oncology Approvals 2025 2026-01-01T04:58:16Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 41 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 42 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 43 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 44 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 45 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 46 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 47 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 48 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar to Perjeta || Biosimilar Study<br /> |-<br /> | 50 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (Traditional Approval) || EPCORE NHL-1<br /> |-<br /> | 51 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || ES-SCLC with disease progression (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 52 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 53 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=164 FDA Oncology Approvals 2025 2026-01-01T04:56:13Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 41 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 42 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 43 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 44 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 45 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 46 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 47 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 48 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar to Perjeta || Biosimilar Study<br /> |-<br /> | 50 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (Traditional Approval) || EPCORE NHL-1<br /> |-<br /> | 51 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || ES-SCLC with disease progression (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 52 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 53 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=163 FDA Oncology Approvals 2025 2026-01-01T04:53:46Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 41 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 42 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 43 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 44 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 45 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 46 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 47 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 48 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar to Perjeta || Biosimilar Study<br /> |-<br /> | 50 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (Traditional Approval) || EPCORE NHL-1<br /> |-<br /> | 51 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || ES-SCLC with disease progression (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 52 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 53 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=162 FDA Oncology Approvals 2025 2026-01-01T04:52:38Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 41 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 42 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 43 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 44 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 45 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 46 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 47 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 48 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar to Perjeta || Biosimilar Study<br /> |-<br /> | 50 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (Traditional Approval) || EPCORE NHL-1<br /> |-<br /> | 51 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || ES-SCLC with disease progression (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 52 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 53 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=161 FDA Oncology Approvals 2025 2026-01-01T04:50:17Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET || CABINET<br /> |-<br /> | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Earlier Use) || PSMAfore<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] &lt;br /&gt; Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] &lt;br /&gt; Defactinib (Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013<br /> |-<br /> | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303<br /> |-<br /> | 27 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION<br /> |-<br /> | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1<br /> |-<br /> | 39 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 40 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT<br /> |-<br /> | 41 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 42 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2- breast cancer || EMBER-3<br /> |-<br /> | 43 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte<br /> |-<br /> | 44 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 45 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 46 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 47 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 48 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar to Perjeta || Biosimilar Study<br /> |-<br /> | 50 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (Traditional Approval) || EPCORE NHL-1<br /> |-<br /> | 51 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || ES-SCLC with disease progression (Traditional Approval) || DeLLphi-301<br /> |-<br /> | 52 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 53 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=160 FDA Oncology Approvals 2025 2026-01-01T04:49:37Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals 2025<br /> ! # !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib + Panitumumab (Lumakras + Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib + Bendamustine + Rituximab (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ELEVATE-TN<br /> |-<br /> | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan + Fludarabine (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 5 || 2025-01-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma || EPCORE NHL-1<br /> |-<br /> | 6 || 2025-01-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001<br /> |-<br /> | 7 || 2025-02-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 8 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor || MOTION<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line unresectable pleural mesothelioma || IND.227<br /> |-<br /> | 10 || 2025-02-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-neoadjuvant-and-adjuvant-treatment-resectable-non-small-cell-lung-cancer Durvalumab (Imfinzi)] || AstraZeneca || Resectable non-small cell lung cancer || AEGEAN<br /> |-<br /> | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-obinutuzumab-relapsed-or-refractory-follicular-lymphoma Zanubrutinib (Brukinsa)] || BeiGene || R/R follicular lymphoma with obinutuzumab || ROSEWOOD<br /> |-<br /> | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-cisplatin-and-gemcitabine-first-line-treatment-unresectable-or-metastatic Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate -901<br /> |-<br /> | 13 || 2025-03-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fr-alpha-positive-platinum-resistant-epithelial-ovarian Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome-positive-acute Ponatinib (Iclusig)] || Takeda || Newly diagnosed Ph+ ALL || PhALLCON<br /> |-<br /> | 15 || 2025-04-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tislelizumab-jsgr-unresectable-or-metastatic-esophageal-squamous-cell-carcinoma Tislelizumab-jsgr (Tevimbra)] || BeiGene || Metastatic esophageal squamous cell carcinoma || RATIONALE-302<br /> |-<br /> | 16 || 2025-04-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-relapsed-or-refractory-multiple-myeloma-0 Idecabtagene vicleucel (Abecma)] || BMS || Relapsed/refractory multiple myeloma (earlier line) || KarMMa-3<br /> |-<br /> | 17 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R multiple myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 18 || 2025-04-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-low-or-her2-ultralow Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 19 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutathera-pediatric-patients-12-years-and-older-gep-nets Lutathera] || Novartis || Pediatric patients with GEP-NETs || NETTER-P<br /> |-<br /> | 20 || 2025-04-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer Tisotumab vedotin-tftv (Tivdak)] || Seagen || Recurrent or metastatic cervical cancer || innovaTV 301<br /> |-<br /> | 21 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-relapsed-or-refractory-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || R/R renal cell carcinoma with nivolumab || TiNivo-2<br /> |-<br /> | 23 || 2025-05-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-chemotherapy-non-small-cell-lung-cancer-ex20ins-mutations Amivantamab-vmjw (Rybrevant)] || Janssen || NSCLC with EGFR Exon 20 insertion mutations || PAPILLON<br /> |-<br /> | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL<br /> |-<br /> | 25 || 2025-06-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-combination-pembrolizumab-recurrent-or-metastatic-endometrial-cancer Selinexor (Xpovio)] || Karyopharm || Recurrent or metastatic endometrial cancer || SIENDO<br /> |-<br /> | 26 || 2025-06-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-cd19-positive-b-cell-precursor-acute-lymphoblastic-leukemia Blinatumomab (Blincyto)] || Amgen || CD19-positive B-cell precursor ALL || E1910<br /> |-<br /> | 27 || 2025-06-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-adagrasib-combination-cetuximab-kras-g12c-mutated-colorectal-cancer Adagrasib (Krazati)] || BMS || KRAS G12C-mutated colorectal cancer || KRYSTAL-1<br /> |-<br /> | 28 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-chemotherapy-endometrial-cancer Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 29 || 2025-07-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-endometrial-cancer Pembrolizumab (Keytruda)] || Merck || Primary advanced or recurrent endometrial cancer || KEYNOTE-868<br /> |-<br /> | 30 || 2025-07-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Epcoritamab-bysp (Epkinly)] || Genmab || R/R DLBCL after failure of CAR-T || EPCORE NHL-1<br /> |-<br /> | 31 || 2025-07-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma Belzutifan (Welireg)] || Merck || Advanced renal cell carcinoma || LITESPARK-005<br /> |-<br /> | 32 || 2025-07-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma Vorasidenib (Voranigo)] || Servier || Grade 2 astrocytoma or oligodendroglioma || INDIGO<br /> |-<br /> | 33 || 2025-08-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-hyaluronidase-fihj-combination-bortezomib-lenalidomide-and-dexamethasone Daratumumab + Hyaluronidase (Darzalex Faspro)] || Janssen || Newly diagnosed multiple myeloma (transplant-eligible) || PERSEUS<br /> |-<br /> | 34 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-afatinib-pediatric-patients-six-years-and-older-advanced-solid-tumors Afatinib (Gilotrif)] || Boehringer Ingelheim || Pediatric advanced solid tumors with ErbB mutations || Study 1200.120<br /> |-<br /> | 35 || 2025-08-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-relapsed-or-refractory-indolent-non-hodgkin-lymphoma Axicabtagene ciloleucel (Yescarta)] || Kite || R/R indolent Non-Hodgkin Lymphoma || ZUMA-5<br /> |-<br /> | 36 || 2025-08-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-combination-amivantamab-vmjw-first-line-treatment-locally-advanced Lazertinib (Leclaza)] || Janssen || First-line EGFR-mutated NSCLC || MARIPOSA<br /> |-<br /> | 37 || 2025-08-29 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-Inotuzumab-ozogamicin-pediatric-patients-one-year-and-older-relapsed-or-refractory Inotuzumab ozogamicin (Besponsa)] || Pfizer || Pediatric R/R B-cell precursor ALL || Study B1931022<br /> |-<br /> | 38 || 2025-09-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-pemetrexed-and-platinum-chemotherapy-first-line-treatment Pembrolizumab (Keytruda)] || Merck || First-line malignant pleural mesothelioma || KEYNOTE-483<br /> |-<br /> | 39 || 2025-09-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-resected-esophageal-or-gastroesophageal-junction-cancer Nivolumab (Opdivo)] || BMS || Adjuvant resected ESCC || CheckMate -577<br /> |-<br /> | 40 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-venetoclax-previously-untreated-chronic-lymphocytic-leukemia Zanubrutinib (Brukinsa)] || BeiGene || Untreated CLL/SLL with venetoclax || SEQUOIA<br /> |-<br /> | 41 || 2025-09-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung Selpercatinib (Retevmo)] || Eli Lilly || RET fusion-positive NSCLC || LIBRETTO-431<br /> |-<br /> | 42 || 2025-10-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-pediatric-patients-older-one-month-ntrk-fusion-positive-solid-tumors Entrectinib (Rozlytrek)] || Genentech || Pediatric NTRK fusion-positive solid tumors || STARTRK-NG<br /> |-<br /> | 43 || 2025-10-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trametinib-combination-dabrafenib-pediatric-patients-low-grade-glioma Trametinib (Mekinist)] || Novartis || Pediatric low-grade glioma with BRAF V600E || Study G2201<br /> |-<br /> | 44 || 2025-10-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-gemcitabine-and-cisplatin-locally-advanced-or-metastatic Pembrolizumab (Keytruda)] || Merck || Advanced or metastatic biliary tract cancer || KEYNOTE-966<br /> |-<br /> | 45 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-doxorubicin-relapsed-small-cell-lung-cancer Lurbinectedin (Zepzelca)] || Jazz Pharma || Relapsed small cell lung cancer || LAGOON<br /> |-<br /> | 46 || 2025-10-31 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-previously-treated-metastatic-colorectal-cancer Fruquintinib (Fruzaqla)] || Takeda || Refractory metastatic colorectal cancer || FRESCO-2<br /> |-<br /> | 47 || 2025-11-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-combination-fulvestrant-advanced-hr-positive-her2-negative-breast-cancer Capivasertib (Truqap)] || AstraZeneca || HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations || CAPItello-291<br /> |-<br /> | 48 || 2025-11-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-locally-advanced-or-metastatic-ros1-positive-non-small-cell-lung-cancer Repotrectinib (Augtyro)] || BMS || ROS1-positive metastatic NSCLC || TRIDENT-1<br /> |-<br /> | 49 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-adult-patients-progressing-desmoid-tumors Nirogacestat (Ogsiveo)] || SpringWorks || Progressing desmoid tumors || DeFi<br /> |-<br /> | 50 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-chemotherapy-neoadjuvant-and-adjuvant-treatment-resectable Durvalumab (Imfinzi)] || AstraZeneca || Resectable NSCLC (perioperative) || AEGEAN<br /> |-<br /> | 51 || 2025-12-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pirtobrutinib-relapsed-or-refractory-chronic-lymphocytic-leukemia-or-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL/SLL after BTK and BCL-2 inhibitors || BRUIN<br /> |-<br /> | 52 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzumig-advanced-clear-cell-renal-cell-carcinoma Belzutifan (Welireg)] || Merck || Advanced clear cell renal cell carcinoma || LITESPARK-005<br /> |-<br /> | 53 || 2025-12-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-second-line-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || Second-line renal cell carcinoma || TiNivo-2<br /> |-<br /> | 54 || 2025-12-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-first-line-advanced-gastric-cancer Pembrolizumab (Keytruda)] || Merck || First-line HER2-negative gastric cancer || KEYNOTE-859<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=159 FDA Oncology Approvals 2025 2026-01-01T04:28:46Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Oncology Approvals &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 4 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 6 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Trastuzumab deruxtecan (Enhertu)] || AstraZeneca || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory Large B-Cell Lymphoma || ECHELON-3<br /> |-<br /> | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 11 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 12 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 14 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 15 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET<br /> |-<br /> | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || Pre-taxane metastatic mCRPC || PSMAfore<br /> |-<br /> | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 21 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 22 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 24 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 25 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 26 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 28 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 29 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE<br /> |-<br /> | 30 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I<br /> |-<br /> | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689<br /> |-<br /> | 32 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION<br /> |-<br /> | 33 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 34 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 35 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6<br /> |-<br /> | 37 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 38 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 39 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1<br /> |-<br /> | 40 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS<br /> |-<br /> | 41 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT<br /> |-<br /> | 42 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86<br /> |-<br /> | 43 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced breast cancer || EMBER-3<br /> |-<br /> | 44 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte<br /> |-<br /> | 45 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST<br /> |-<br /> | 46 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7<br /> |-<br /> | 47 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 48 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA<br /> |-<br /> | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Full Approval) || DeLLphi-301<br /> |-<br /> | 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (Full Approval) || BRUIN<br /> |-<br /> | 53 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib (Akeega)] || Janssen || BRCA2-mutated mCSPC || MAGNITUDE<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=158 FDA Oncology Approvals 2025 2026-01-01T04:18:38Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Approved Oncology Drugs &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 4 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 6 || 2025-01-27 || [https://www.aptitudehealth.com/oncology-news/most-fda-and-ema-oncology-drug-approvals-in-q1-2025-were-new-indications-for-biologics-and-biosimilars/ Trastuzumab deruxtecan (Enhertu)] || AstraZeneca || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 7 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 9 || 2025-02-11 || [https://www.aptitudehealth.com/oncology-news Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory Large B-Cell Lymphoma || Phase 3 trial<br /> |-<br /> | 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 11 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 12 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line PD-L1+ esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 13 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 14 || 2025-03-07 || [https://www.aptitudehealth.com/oncology-news Dabrafenib mesylate (Tafinlar)] || Novartis || Expanded use in pediatric BRAF-mutant melanoma || Pediatric Study<br /> |-<br /> | 15 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 16 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Binimetinib (Mektovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial<br /> |-<br /> | 17 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Encorafenib (Braftovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial<br /> |-<br /> | 18 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 19 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 20 || 2025-03-25 || [https://www.aptitudehealth.com/oncology-news Denosumab (Osenvelt)] || Fresenius Kabi || Biosimilar for prostate and breast cancer bone loss || Biosimilar Study<br /> |-<br /> | 21 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET<br /> |-<br /> | 22 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || Pre-taxane metastatic prostate cancer || PSMAfore<br /> |-<br /> | 23 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 24 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 25 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for CRC, NSCLC, and other solid tumors || Biosimilar Study<br /> |-<br /> | 26 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion-positive solid tumors || NAVIGATE<br /> |-<br /> | 27 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 28 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 29 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 30 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso Biopharma || Metastatic non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 31 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded use in HR+/HER2- breast cancer || PALOMA-2<br /> |-<br /> | 32 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 33 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 34 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 35 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 36 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Metastatic pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 37 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 38 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 39 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I<br /> |-<br /> | 40 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Neoadjuvant/adjuvant locally advanced head and neck cancer || Phase 3 trial<br /> |-<br /> | 41 || 2025-06-12 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mitomycin (Zusduri)] || UroGen Pharma || Recurrent low-grade non-muscle invasive bladder cancer || Phase 3 Study<br /> |-<br /> | 42 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 43 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 44 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 45 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant metastatic NSCLC || WU-KONG6<br /> |-<br /> | 46 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2 TKD-mutant non-squamous metastatic NSCLC || Beamion LUNG-1<br /> |-<br /> | 49 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous adult/pediatric solid tumor indications || MK-3475<br /> |-<br /> | 50 || 2025-09-25 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 51 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 52 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 53 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] || Janssen || Subcutaneous NSCLC delivery (All indications) || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=157 FDA Oncology Approvals 2025 2026-01-01T04:16:19Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ Verified FDA Oncology Approvals 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 4 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 7 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 9 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD<br /> |-<br /> | 10 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 11 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 12 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || Metastatic nonsquamous NSCLC || LUMINOSITY<br /> |-<br /> | 13 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I<br /> |-<br /> | 14 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || R/R Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 15 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 16 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutant metastatic NSCLC || Beamion LUNG-1<br /> |-<br /> | 17 || 2025-09-25 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated breast cancer || EMBER-3<br /> |-<br /> | 18 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || R/R AML with NPM1 mutation || AUGMENT-101<br /> |-<br /> | 19 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001<br /> |-<br /> | 20 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || Traditional Approval: R/R CLL/SLL || BRUIN<br /> |-<br /> | 21 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib (Akeega)] || Janssen || BRCA2-mutated mCSPC || MAGNITUDE<br /> |-<br /> | 22 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab (Rybrevant Faspro)] || Janssen || Subcutaneous NSCLC formulation || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=156 FDA Oncology Approvals 2025 2026-01-01T04:14:53Z <p>Qiangnai: </p> <hr /> <div>{| class=&quot;wikitable sortable&quot;<br /> |+ FDA Approved Oncology Drugs &amp; Major Label Updates 2025<br /> ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name<br /> |-<br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300<br /> |-<br /> | 3 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO<br /> |-<br /> | 4 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01<br /> |-<br /> | 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L<br /> |-<br /> | 6 || 2025-01-27 || [https://www.aptitudehealth.com/oncology-news/most-fda-and-ema-oncology-drug-approvals-in-q1-2025-were-new-indications-for-biologics-and-biosimilars/ Trastuzumab deruxtecan (Enhertu)] || AstraZeneca || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06<br /> |-<br /> | 7 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study<br /> |-<br /> | 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu<br /> |-<br /> | 9 || 2025-02-11 || [https://www.aptitudehealth.com/oncology-news Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory Large B-Cell Lymphoma || Phase 3 trial<br /> |-<br /> | 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION<br /> |-<br /> | 11 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227<br /> |-<br /> | 12 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line PD-L1+ esophageal squamous cell carcinoma || RATIONALE-306<br /> |-<br /> | 13 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD<br /> |-<br /> | 14 || 2025-03-07 || [https://www.aptitudehealth.com/oncology-news Dabrafenib mesylate (Tafinlar)] || Novartis || Expanded use in pediatric BRAF-mutant melanoma || Pediatric Study<br /> |-<br /> | 15 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901<br /> |-<br /> | 16 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Binimetinib (Mektovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial<br /> |-<br /> | 17 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Encorafenib (Braftovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial<br /> |-<br /> | 18 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811<br /> |-<br /> | 19 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL<br /> |-<br /> | 20 || 2025-03-25 || [https://www.aptitudehealth.com/oncology-news Denosumab (Osenvelt)] || Fresenius Kabi || Biosimilar for prostate and breast cancer bone loss || Biosimilar Study<br /> |-<br /> | 21 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET<br /> |-<br /> | 22 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || Pre-taxane metastatic prostate cancer || PSMAfore<br /> |-<br /> | 23 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 24 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW<br /> |-<br /> | 25 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for CRC, NSCLC, and other solid tumors || Biosimilar Study<br /> |-<br /> | 26 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion-positive solid tumors || NAVIGATE<br /> |-<br /> | 27 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4<br /> |-<br /> | 28 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 29 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW<br /> |-<br /> | 30 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso Biopharma || Metastatic non-keratinizing nasopharyngeal carcinoma || AK105-302<br /> |-<br /> | 31 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded use in HR+/HER2- breast cancer || PALOMA-2<br /> |-<br /> | 32 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 33 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201<br /> |-<br /> | 34 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121<br /> |-<br /> | 35 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY<br /> |-<br /> | 36 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Metastatic pheochromocytoma or paraganglioma || LITESPARK-013<br /> |-<br /> | 37 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303<br /> |-<br /> | 38 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL<br /> |-<br /> | 39 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I<br /> |-<br /> | 40 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Neoadjuvant/adjuvant locally advanced head and neck cancer || Phase 3 trial<br /> |-<br /> | 41 || 2025-06-12 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mitomycin (Zusduri)] || UroGen Pharma || Recurrent low-grade non-muscle invasive bladder cancer || Phase 3 Study<br /> |-<br /> | 42 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND<br /> |-<br /> | 43 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01<br /> |-<br /> | 44 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E<br /> |-<br /> | 45 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant metastatic NSCLC || WU-KONG6<br /> |-<br /> | 46 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1<br /> |-<br /> | 47 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201<br /> |-<br /> | 48 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2 TKD-mutant non-squamous metastatic NSCLC || Beamion LUNG-1<br /> |-<br /> | 49 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous adult/pediatric solid tumor indications || MK-3475<br /> |-<br /> | 50 || 2025-09-25 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced or metastatic breast cancer || EMBER-3<br /> |-<br /> | 51 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101<br /> |-<br /> | 52 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001<br /> |-<br /> | 53 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN<br /> |-<br /> | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] || Janssen || Subcutaneous NSCLC delivery (All indications) || PALOMA-3<br /> |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=155 FDA Oncology Approvals 2025 2026-01-01T04:13:33Z <p>Qiangnai: </p> <hr /> <div>| class=&quot;wikitable sortable&quot; |+ FDA Oncology Approvals &amp; Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |- <br /> | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] &lt;br /&gt; Bendamustine &lt;br /&gt; Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |- | 3 || 2025-01-17 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 4 || 2025-01-21 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Treosulfan (Grafapex)] &lt;br /&gt; Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227 |- | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line PD-L1+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |- | 11 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 |- | 12 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 |- | 13 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL |- | 14 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET |- | 15 || 2025-03-28 || [https://www.mskcc.org/news/msk-led-research-resulted-in-11-new-fda-approvals-for-cancer-drugs-in-2025 177Lu-PSMA-617 (Pluvicto)] || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Fitusiran (Qfitlia)] || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Atrasentan (Vanrafia)] || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || [https://ascopost.com/issues/december-10-2025/new-fda-approved-oncology-drugs-and-label-updates-between-december-1-2024-and-november-19-2025/ Nivolumab (Opdivo)] &lt;br /&gt; [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || [https://ascopost.com/issues/december-10-2025 Nivolumab (Opdivo)] &lt;br /&gt; [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || [https://www.aptitudehealth.com/oncology-news Palonosetron (Posfrea)] || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Penpulimab-kcqx (Anike)] || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Nipocalimab-aahu (Imaavy)] || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.mskcc.org/news Defactinib (Avmapki Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121 |- | 29 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY |- | 30 || 2025-05-14 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL |- | 34 || 2025-06-03 || [https://ascopost.com/issues/december-10-2025 Darolutamide (Nubeqa)] || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 36 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Talazoparib (Talzenna)] || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Mitomycin (Zusduri)] || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || [https://ascopost.com/issues/december-10-2025 Tafasitamab-cxix (Monjuvi)] &lt;br /&gt; Lenalidomide &lt;br /&gt; Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || [https://ascopost.com/issues/december-10-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || [https://ascopost.com/issues/december-10-2025 Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1 |- | 44 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 45 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || [https://www.cancernetwork.com/view/spotlighting-the-top-10-fda-oncology-approvals-in-2025 Leuprolide Mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || [https://ascopost.com/issues/december-10-2025 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || [https://www.mskcc.org/news Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || [https://www.mskcc.org/news Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || [https://ascopost.com/issues/december-10-2025 Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 53 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN |- | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] &lt;br /&gt; Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |}</div> Qiangnai https://neoplasm.org/index.php?title=FDA_Oncology_Approvals_2025&diff=154 FDA Oncology Approvals 2025 2026-01-01T04:12:54Z <p>Qiangnai: </p> <hr /> <div>| class=&quot;wikitable sortable&quot; |+ FDA Oncology Approvals &amp; Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |- | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] &lt;br /&gt; [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] &lt;br /&gt; Bendamustine &lt;br /&gt; Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |- | 3 || 2025-01-17 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 4 || 2025-01-21 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Treosulfan (Grafapex)] &lt;br /&gt; Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227 |- | 9 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line PD-L1+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |- | 11 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 |- | 12 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 |- | 13 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL |- | 14 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET |- | 15 || 2025-03-28 || [https://www.mskcc.org/news/msk-led-research-resulted-in-11-new-fda-approvals-for-cancer-drugs-in-2025 177Lu-PSMA-617 (Pluvicto)] || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Fitusiran (Qfitlia)] || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Atrasentan (Vanrafia)] || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || [https://ascopost.com/issues/december-10-2025/new-fda-approved-oncology-drugs-and-label-updates-between-december-1-2024-and-november-19-2025/ Nivolumab (Opdivo)] &lt;br /&gt; [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || [https://ascopost.com/issues/december-10-2025 Nivolumab (Opdivo)] &lt;br /&gt; [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || [https://www.aptitudehealth.com/oncology-news Palonosetron (Posfrea)] || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Penpulimab-kcqx (Anike)] || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Nipocalimab-aahu (Imaavy)] || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] &lt;br /&gt; [https://www.mskcc.org/news Defactinib (Avmapki Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121 |- | 29 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY |- | 30 || 2025-05-14 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL |- | 34 || 2025-06-03 || [https://ascopost.com/issues/december-10-2025 Darolutamide (Nubeqa)] || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 36 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Talazoparib (Talzenna)] || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Mitomycin (Zusduri)] || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || [https://ascopost.com/issues/december-10-2025 Tafasitamab-cxix (Monjuvi)] &lt;br /&gt; Lenalidomide &lt;br /&gt; Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || [https://ascopost.com/issues/december-10-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || [https://ascopost.com/issues/december-10-2025 Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1 |- | 44 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 45 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || [https://www.cancernetwork.com/view/spotlighting-the-top-10-fda-oncology-approvals-in-2025 Leuprolide Mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || [https://ascopost.com/issues/december-10-2025 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || [https://www.mskcc.org/news Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || [https://www.mskcc.org/news Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || [https://ascopost.com/issues/december-10-2025 Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 53 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN |- | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] &lt;br /&gt; Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |}</div> Qiangnai