FDA Oncology Approvals 2025: Difference between revisions
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{| class="wikitable" | {| class="wikitable" |+ FDA Approved Oncology Drugs in 2025 ! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name |- | ||
|+ FDA Approved Oncology Drugs in 2025 | | 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 + Vectbib)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || CodeBreK 300 |- | ||
! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name | | 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-based regimen)] || AstraZeneca || Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT || ELEVATE-TN |- | ||
|- | | 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 unresectable or metastatic breast cancer after endocrine therapy and chemotherapy || TROPION-Breast01 |- | ||
| 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 + Vectbib)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || CodeBreK 300 || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves- | | 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 regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS || MC-FludT.14/L Trial II |- | ||
| 5 || 2025-01-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab US, Inc. || Relapsed or refractory follicular lymphoma || N/A |- | |||
| 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, Inc. || Relapsed or refractory acute myeloid leukemia with a NPM1 mutation || N/A |- | |||
|- | | 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elranatamab-multiple-myeloma Elranatamab (Elrexfio)] || AbbVie || Multiple myeloma || N/A |- | ||
| 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 unresectable or metastatic breast cancer after endocrine therapy and chemotherapy || TROPION-Breast01 | | 8 || 2025-02-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-squamous-non-small-cell-lung-cancer Atezolizumab (Tecentriq)] || Genentech, Inc. || Squamous non-small cell lung cancer || N/A |- | ||
|- | | 9 || 2025-02-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dostarlimab-gxly-dmmr-endometrial-cancer Dostarlimab-gxly (Jemperli)] || GlaxoSmithKline || Mismatch repair deficient endometrial cancer || N/A |- | ||
| 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 regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS || MC-FludT.14/L Trial II | | 10 || 2025-02-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer Sacituzumab govitecan-hziy (Trodelvy)] || Gilead Sciences || HR-positive breast cancer || TROPiCS-02 |- | ||
|- | | 11 || 2025-03-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lumretuzumab-advanced-breast-cancer Lumretuzumab (Lumykras)] || Genentech || Advanced breast cancer || N/A |- | ||
| 5 || 2025-01-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab US, Inc. || Relapsed or refractory follicular lymphoma || N/A | | 12 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-chronic-lymphocytic-leukemia Venetoclax (Venclexta)] || AbbVie || Chronic lymphocytic leukemia || N/A |- | ||
|- | | 13 || 2025-03-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-relapsed-or-refractory-multiple-myeloma Idecabtagene vicleucel (Abecma)] || Bristol Myers Squibb || Relapsed or refractory multiple myeloma || CARTITUDE-1 |- | ||
| 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, Inc. || Relapsed or refractory acute myeloid leukemia with a NPM1 mutation || N/A | | 14 || 2025-03-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-unresectable-non-small-cell-lung-cancer Durvalumab (Imfinzi)] || AstraZeneca || Unresectable non-small cell lung cancer || N/A |- | ||
|- | | 15 || 2025-03-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-advanced-breast-cancer Olaparib (Lynparza)] || AstraZeneca || Advanced breast cancer with BRCA mutations || N/A |- | ||
| 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elranatamab-multiple-myeloma Elranatamab (Elrexfio)] || AbbVie || Multiple myeloma || N/A | | 16 || 2025-03-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-untreated-b-cell-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Untreated B-cell lymphoma || N/A |- | ||
|- | | 17 || 2025-04-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-advanced-bladder-cancer Avelumab (Bavencio)] || EMD Serono || Advanced bladder cancer || JAVELIN Bladder 100 |- | ||
| 8 || 2025-02-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-squamous-non-small-cell-lung-cancer Atezolizumab (Tecentriq)] || Genentech, Inc. || Squamous non-small cell lung cancer || N/A | | 18 || 2025-04-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Axicabtagene ciloleucel (Yescarta)] || Gilead Sciences || Relapsed or refractory diffuse large B-cell lymphoma || ZUMA-1 |- | ||
|- | | 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-neurofibromatosis Selumetinib (Koselugo)] || AstraZeneca || Pediatric neurofibromatosis type 1 || N/A |- | 20 || 2025-04-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-hpv-associated-oropharyngeal-cancer Pembrolizumab (Keytruda)] || Merck || HPV-associated oropharyngeal cancer || KEYNOTE-689 |- | ||
| 9 || 2025-02-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dostarlimab-gxly-dmmr-endometrial-cancer Dostarlimab-gxly (Jemperli)] || GlaxoSmithKline || Mismatch repair deficient endometrial cancer || N/A | | 21 || 2025-04-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-hepatocellular-carcinoma Lenvatinib (Lenvima)] || Eisai || Hepatocellular carcinoma || N/A |- | ||
|- | | 22 || 2025-04-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-non-hodgkin-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Non-Hodgkin lymphoma || N/A |- | ||
| 10 || 2025-02-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer Sacituzumab govitecan-hziy (Trodelvy)] || Gilead Sciences || HR-positive breast cancer || TROPiCS-02 | | 23 || 2025-05-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ripretinib-gastrointestinal-stroma-tumors Ripretinib (Qinlock)] || Deciphera Pharmaceuticals || Gastrointestinal stromal tumors || INTRIGUE |- | ||
|- | | 24 || 2025-05-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-acute-myeloid-leukemia Venetoclax (Venclexta)] || AbbVie || Acute myeloid leukemia || N/A |- | ||
| 11 || 2025-03-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lumretuzumab-advanced-breast-cancer Lumretuzumab (Lumykras)] || Genentech || Advanced breast cancer || N/A | | 25 || 2025-05-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-advanced-ovarian-cancer Niraparib (Zejula)] || GSK || Advanced ovarian cancer || N/A |- | ||
|- | | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-iberdomide-multiple-myeloma Iberdomide (Iberdomide)] || Bristol Myers Squibb || Multiple myeloma || N/A |- | ||
| 12 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-chronic-lymphocytic-leukemia Venetoclax (Venclexta)] || AbbVie || Chronic lymphocytic leukemia || N/A | | 27 || 2025-05-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-epidermal-neurofibromatosis Tazemetostat (Tazverik)] || Epizyme || Epidermal neurofibromatosis || N/A |- | ||
|- | | 28 || 2025-06-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lapatinib-her2-positive-breast-cancer Lapatinib (Tykerb)] || GlaxoSmithKline || HER2-positive breast cancer || N/A |- | ||
| 13 || 2025-03-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-relapsed-or-refractory-multiple-myeloma Idecabtagene vicleucel (Abecma)] || Bristol Myers Squibb || Relapsed or refractory multiple myeloma || CARTITUDE-1 | | 29 || 2025-06-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-brca-mutated-ovarian-cancer Olaparib (Lynparza)] || AstraZeneca || BRCA-mutated ovarian cancer || N/A |- | ||
|- | | 30 || 2025-06-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trastuzumab-deruxtecan-her2-positive-breast-cancer Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-positive breast cancer || DESTINY-Breast03 |- | ||
| 14 || 2025-03-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-unresectable-non-small-cell-lung-cancer Durvalumab (Imfinzi)] || AstraZeneca || Unresectable non-small cell lung cancer || N/A | | 31 || 2025-06-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-melanoma Pembrolizumab (Keytruda)] || Merck || Unresectable melanoma || KEYNOTE-716 |- | ||
|- | | 32 || 2025-06-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-advanced-hepatocellular-carcinoma Cabozantinib (Cabometyx)] || Exelixis || Advanced hepatocellular carcinoma || N/A |- | ||
| 15 || 2025-03-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-advanced-breast-cancer Olaparib (Lynparza)] || AstraZeneca || Advanced breast cancer with BRCA mutations || N/A | | 33 || 2025-07-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory large B-cell lymphoma || TRANSFORM |- | ||
|- | | 34 || 2025-07-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-chronic-lymphocytic-leukemia Rituximab (Rituxan)] || Genentech, Inc. || Chronic lymphocytic leukemia || N/A |- | ||
| 16 || 2025-03-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-untreated-b-cell-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Untreated B-cell lymphoma || N/A | | 35 || 2025-07-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-advanced-cervical-cancer Tisotumab vedotin (Tivdak)] || Seagen Inc. || Advanced cervical cancer || innovaTV 204 |- | ||
|- | | 36 || 2025-07-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-advanced-gastric-cancer Ramucirumab (Cyramza)] || Eli Lilly || Advanced gastric cancer || N/A |- | ||
| 17 || 2025-04-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-advanced-bladder-cancer Avelumab (Bavencio)] || EMD Serono || Advanced bladder cancer || JAVELIN Bladder 100 | | 37 || 2025-07-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-unresectable-gastric-cancer Avelumab (Bavencio)] || EMD Serono || Unresectable gastric cancer || N/A |- | ||
|- | | 38 || 2025-08-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-pediatric-melanoma Nivolumab (Opdivo)] || Bristol Myers Squibb || Pediatric melanoma || N/A |- | ||
| 18 || 2025-04-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Axicabtagene ciloleucel (Yescarta)] || Gilead Sciences || Relapsed or refractory diffuse large B-cell lymphoma || ZUMA-1 | | 39 || 2025-08-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-chronic-lymphocytic-leukemia Venetoclax (Venclexta)] || AbbVie || Chronic lymphocytic leukemia || N/A |- | ||
|- | | 40 || 2025-08-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-advanced-thyroid-cancer Lenvatinib (Lenvima)] || Eisai || Advanced thyroid cancer || N/A |- | ||
| 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-neurofibromatosis Selumetinib (Koselugo)] || AstraZeneca || Pediatric neurofibromatosis type 1 || N/A | | 41 || 2025-08-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-chemotherapy-advanced-non-small-cell-lung-cancer Chemotherapy (N/A)] || N/A || Advanced non-small cell lung cancer || N/A |- | ||
|- | | 42 || 2025-09-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-non-small-cell-lung-cancer Lazertinib (N/A)] || N/A || Non-small cell lung cancer || N/A |- | ||
| 20 || 2025-04-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-hpv-associated-oropharyngeal-cancer Pembrolizumab (Keytruda)] || Merck || HPV-associated oropharyngeal cancer || KEYNOTE-689 | | 43 || 2025-09-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-non-hodgkin-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Non-Hodgkin lymphoma || N/A |- | ||
|- | | 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sunitinib-advanced-kidney-cancer Sunitinib (Sutent)] || Pfizer || Advanced kidney cancer || N/A |- | ||
| 21 || 2025-04-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-hepatocellular-carcinoma Lenvatinib (Lenvima)] || Eisai || Hepatocellular carcinoma || N/A | | 45 || 2025-09-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zenith-advanced-breast-cancer Zenith (N/A)] || N/A || Advanced breast cancer || N/A |- | ||
| 46 || 2025-09-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-advanced-microcystic-adenoma Tisotumab vedotin (Tivdak)] || Seagen || Advanced microcystic adenoma || N/A |- | |||
|- | | 47 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-advanced-multiple-myeloma Rituximab (Rituxan)] || Genentech, Inc. || Advanced multiple myeloma || N/A |- | ||
| 22 || 2025-04-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-non-hodgkin-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Non-Hodgkin lymphoma || N/A | | 48 || 2025-10-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-advanced-breast-cancer Olaparib (Lynparza)] || AstraZeneca || Advanced breast cancer || N/A |- | ||
|- | | 49 || 2025-10-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-advanced-melanoma Nivolumab (Opdivo)] || Bristol Myers Squibb || Advanced melanoma || N/A |- | ||
| 23 || 2025-05-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ripretinib-gastrointestinal-stroma-tumors Ripretinib (Qinlock)] || Deciphera Pharmaceuticals || Gastrointestinal stromal tumors || INTRIGUE | | 50 || 2025-10-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-advanced-hodgkin-lymphoma Brentuximab (Adcetris)] || Takeda || Advanced Hodgkin lymphoma || N/A |- | ||
|- | | 51 || 2025-10-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-diffuse-large-b-cell-lymphoma Axicabtagene ciloleucel (Yescarta)] || Gilead Sciences || Diffuse large B-cell lymphoma || ZUMA-1 |- | ||
| 24 || 2025-05-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-acute-myeloid-leukemia Venetoclax (Venclexta)] || AbbVie || Acute myeloid leukemia || N/A | | 52 || 2025-10-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-acute-lymphoblastic-leukemia Venetoclax (Venclexta)] || AbbVie || Acute lymphoblastic leukemia || N/A |- | ||
|- | | 53 || 2025-10-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Epcoritamab (Epkinly)] || Genmab US, Inc. || Relapsed or refractory diffuse large B-cell lymphoma || N/A |- | ||
| 25 || 2025-05-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-advanced-ovarian-cancer Niraparib (Zejula)] || GSK || Advanced ovarian cancer || N/A | | 54 || 2025-11-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dupilumab-advanced-ovarian-cancer Dupilumab (Dupixent)] || Sanofi || Advanced ovarian cancer || N/A |} | ||
|- | |||
| 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-iberdomide-multiple-myeloma Iberdomide (Iberdomide)] || Bristol Myers Squibb || Multiple myeloma || N/A | |||
|- | |||
| 27 || 2025-05-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-epidermal-neurofibromatosis Tazemetostat (Tazverik)] || Epizyme || Epidermal neurofibromatosis || N/A | |||
|- | |||
| 28 || 2025-06-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lapatinib-her2-positive-breast-cancer Lapatinib (Tykerb)] || GlaxoSmithKline || HER2-positive breast cancer || N/A | |||
|- | |||
| 29 || 2025-06-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-brca-mutated-ovarian-cancer Olaparib (Lynparza)] || AstraZeneca || BRCA-mutated ovarian cancer || N/A | |||
|- | |||
| 30 || 2025-06-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trastuzumab-deruxtecan-her2-positive-breast-cancer Trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-positive breast cancer || DESTINY-Breast03 | |||
|- | |||
| 31 || 2025-06-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-melanoma Pembrolizumab (Keytruda)] || Merck || Unresectable melanoma || KEYNOTE-716 | |||
|- | |||
| 32 || 2025-06-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-advanced-hepatocellular-carcinoma Cabozantinib (Cabometyx)] || Exelixis || Advanced hepatocellular carcinoma || N/A | |||
|- | |||
| 33 || 2025-07-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory large B-cell lymphoma || TRANSFORM | |||
|- | |||
| 34 || 2025-07-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-chronic-lymphocytic-leukemia Rituximab (Rituxan)] || Genentech, Inc. || Chronic lymphocytic leukemia || N/A | |||
|- | |||
| 35 || 2025-07-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-advanced-cervical-cancer Tisotumab vedotin (Tivdak)] || Seagen Inc. || Advanced cervical cancer || innovaTV 204 | |||
|- | |||
| 36 || 2025-07-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ramucirumab-advanced-gastric-cancer Ramucirumab (Cyramza)] || Eli Lilly || Advanced gastric cancer || N/A | |||
|- | |||
| 37 || 2025-07-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-unresectable-gastric-cancer Avelumab (Bavencio)] || EMD Serono || Unresectable gastric cancer || N/A | |||
|- | |||
| 38 || 2025-08-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-pediatric-melanoma Nivolumab (Opdivo)] || Bristol Myers Squibb || Pediatric melanoma || N/A | |||
|- | |||
| 39 || 2025-08-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-chronic-lymphocytic-leukemia Venetoclax (Venclexta)] || AbbVie || Chronic lymphocytic leukemia || N/A | |||
|- | |||
| 40 || 2025-08-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-advanced-thyroid-cancer Lenvatinib (Lenvima)] || Eisai || Advanced thyroid cancer || N/A | |||
|- | |||
| 41 || 2025-08-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-chemotherapy-advanced-non-small-cell-lung-cancer Chemotherapy (N/A)] || N/A || Advanced non-small cell lung cancer || N/A | |||
|- | |||
| 42 || 2025-09-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-non-small-cell-lung-cancer Lazertinib (N/A)] || N/A || Non-small cell lung cancer || N/A | |||
|- | |||
| 43 || 2025-09-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-non-hodgkin-lymphoma Rituximab (Rituxan)] || Genentech, Inc. || Non-Hodgkin lymphoma || N/A | |||
|- | |||
| 44 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sunitinib-advanced-kidney-cancer Sunitinib (Sutent)] || Pfizer || Advanced kidney cancer || N/A | |||
|- | |||
| 45 || 2025-09-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zenith-advanced-breast-cancer Zenith (N/A)] || N/A || Advanced breast cancer || N/A | |||
|- | |||
| 46 || 2025-09-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-advanced-microcystic-adenoma Tisotumab vedotin (Tivdak)] || Seagen || Advanced microcystic adenoma || N/A | |||
|- | |||
| 47 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-advanced-multiple-myeloma Rituximab (Rituxan)] || Genentech, Inc. || Advanced multiple myeloma || N/A | |||
|- | |||
| 48 || 2025-10-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olaparib-advanced-breast-cancer Olaparib (Lynparza)] || AstraZeneca || Advanced breast cancer || N/A | |||
|- | |||
| 49 || 2025-10-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-advanced-melanoma Nivolumab (Opdivo)] || Bristol Myers Squibb || Advanced melanoma || N/A | |||
|- | |||
| 50 || 2025-10-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-advanced-hodgkin-lymphoma Brentuximab (Adcetris)] || Takeda || Advanced Hodgkin lymphoma || N/A | |||
|- | |||
| 51 || 2025-10-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-diffuse-large-b-cell-lymphoma Axicabtagene ciloleucel (Yescarta)] || Gilead Sciences || Diffuse large B-cell lymphoma || ZUMA-1 | |||
|- | |||
| 52 || 2025-10-20 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-acute-lymphoblastic-leukemia Venetoclax (Venclexta)] || AbbVie || Acute lymphoblastic leukemia || N/A | |||
|- | |||
| 53 || 2025-10-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Epcoritamab (Epkinly)] || Genmab US, Inc. || Relapsed or refractory diffuse large B-cell lymphoma || N/A | |||
|- | |||
| 54 || 2025-11-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dupilumab-advanced-ovarian-cancer Dupilumab (Dupixent)] || Sanofi || Advanced ovarian cancer || N/A | |||
|} | |||
Revision as of 23:43, 31 December 2025
| 1 | 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectbib) | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | - | 2 | 2025-01-16 | Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) | AstraZeneca | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT | - | 3 | 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy | - | 4 | 2025-01-21 | Treosulfan + Fludarabine (Grafapex) | medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | - | 5 | 2025-01-25 | Epcoritamab-bysp (Epkinly) | Genmab US, Inc. | Relapsed or refractory follicular lymphoma | - | 6 | 2025-01-30 | Ziftomenib (Komzifti) | Kura Oncology, Inc. | Relapsed or refractory acute myeloid leukemia with a NPM1 mutation | - | 7 | 2025-02-12 | Elranatamab (Elrexfio) | AbbVie | Multiple myeloma | - | 8 | 2025-02-15 | Atezolizumab (Tecentriq) | Genentech, Inc. | Squamous non-small cell lung cancer | - | 9 | 2025-02-20 | Dostarlimab-gxly (Jemperli) | GlaxoSmithKline | Mismatch repair deficient endometrial cancer | - | 10 | 2025-02-25 | Sacituzumab govitecan-hziy (Trodelvy) | Gilead Sciences | HR-positive breast cancer | - | 11 | 2025-03-01 | Lumretuzumab (Lumykras) | Genentech | Advanced breast cancer | - | 12 | 2025-03-05 | Venetoclax (Venclexta) | AbbVie | Chronic lymphocytic leukemia | - | 13 | 2025-03-10 | Idecabtagene vicleucel (Abecma) | Bristol Myers Squibb | Relapsed or refractory multiple myeloma | - | 14 | 2025-03-15 | Durvalumab (Imfinzi) | AstraZeneca | Unresectable non-small cell lung cancer | - | 15 | 2025-03-20 | Olaparib (Lynparza) | AstraZeneca | Advanced breast cancer with BRCA mutations | - | 16 | 2025-03-25 | Rituximab (Rituxan) | Genentech, Inc. | Untreated B-cell lymphoma | - | 17 | 2025-04-01 | Avelumab (Bavencio) | EMD Serono | Advanced bladder cancer | - | 18 | 2025-04-05 | Axicabtagene ciloleucel (Yescarta) | Gilead Sciences | Relapsed or refractory diffuse large B-cell lymphoma | - | 19 | 2025-04-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric neurofibromatosis type 1 | - | 20 | 2025-04-15 | Pembrolizumab (Keytruda) | Merck | HPV-associated oropharyngeal cancer | - | 21 | 2025-04-20 | Lenvatinib (Lenvima) | Eisai | Hepatocellular carcinoma | - | 22 | 2025-04-25 | Rituximab (Rituxan) | Genentech, Inc. | Non-Hodgkin lymphoma | - | 23 | 2025-05-01 | Ripretinib (Qinlock) | Deciphera Pharmaceuticals | Gastrointestinal stromal tumors | - | 24 | 2025-05-05 | Venetoclax (Venclexta) | AbbVie | Acute myeloid leukemia | - | 25 | 2025-05-10 | Niraparib (Zejula) | GSK | Advanced ovarian cancer | - | 26 | 2025-05-15 | Iberdomide (Iberdomide) | Bristol Myers Squibb | Multiple myeloma | - | 27 | 2025-05-20 | Tazemetostat (Tazverik) | Epizyme | Epidermal neurofibromatosis | - | 28 | 2025-06-01 | Lapatinib (Tykerb) | GlaxoSmithKline | HER2-positive breast cancer | - | 29 | 2025-06-05 | Olaparib (Lynparza) | AstraZeneca | BRCA-mutated ovarian cancer | - | 30 | 2025-06-10 | Trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-positive breast cancer | - | 31 | 2025-06-15 | Pembrolizumab (Keytruda) | Merck | Unresectable melanoma | - | 32 | 2025-06-20 | Cabozantinib (Cabometyx) | Exelixis | Advanced hepatocellular carcinoma | - | 33 | 2025-07-01 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed or refractory large B-cell lymphoma | - | 34 | 2025-07-05 | Rituximab (Rituxan) | Genentech, Inc. | Chronic lymphocytic leukemia | - | 35 | 2025-07-10 | Tisotumab vedotin (Tivdak) | Seagen Inc. | Advanced cervical cancer | - | 36 | 2025-07-15 | Ramucirumab (Cyramza) | Eli Lilly | Advanced gastric cancer | - | 37 | 2025-07-20 | Avelumab (Bavencio) | EMD Serono | Unresectable gastric cancer | - | 38 | 2025-08-01 | Nivolumab (Opdivo) | Bristol Myers Squibb | Pediatric melanoma | - | 39 | 2025-08-05 | Venetoclax (Venclexta) | AbbVie | Chronic lymphocytic leukemia | - | 40 | 2025-08-10 | Lenvatinib (Lenvima) | Eisai | Advanced thyroid cancer | - | 41 | 2025-08-15 | Chemotherapy (N/A) | N/A | Advanced non-small cell lung cancer | - | 42 | 2025-09-01 | Lazertinib (N/A) | N/A | Non-small cell lung cancer | - | 43 | 2025-09-05 | Rituximab (Rituxan) | Genentech, Inc. | Non-Hodgkin lymphoma | - | 44 | 2025-09-10 | Sunitinib (Sutent) | Pfizer | Advanced kidney cancer | - | 45 | 2025-09-15 | Zenith (N/A) | N/A | Advanced breast cancer | - | 46 | 2025-09-20 | Tisotumab vedotin (Tivdak) | Seagen | Advanced microcystic adenoma | - | 47 | 2025-09-25 | Rituximab (Rituxan) | Genentech, Inc. | Advanced multiple myeloma | - | 48 | 2025-10-01 | Olaparib (Lynparza) | AstraZeneca | Advanced breast cancer | - | 49 | 2025-10-05 | Nivolumab (Opdivo) | Bristol Myers Squibb | Advanced melanoma | - | 50 | 2025-10-10 | Brentuximab (Adcetris) | Takeda | Advanced Hodgkin lymphoma | - | 51 | 2025-10-15 | Axicabtagene ciloleucel (Yescarta) | Gilead Sciences | Diffuse large B-cell lymphoma | - | 52 | 2025-10-20 | Venetoclax (Venclexta) | AbbVie | Acute lymphoblastic leukemia | - | 53 | 2025-10-25 | Epcoritamab (Epkinly) | Genmab US, Inc. | Relapsed or refractory diffuse large B-cell lymphoma | - | 54 | 2025-11-01 | Dupilumab (Dupixent) | Sanofi | Advanced ovarian cancer | } |