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FDA Oncology Approvals 2025: Difference between revisions

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|+ FDA Approved Oncology Drugs in 2025
|+ FDA Oncology Approvals 2025
! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name
! # !! Approval Date !! Medication (Brand) !! 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 + Panitumumab (Lumakras + Vectbib)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || CodeBreK 300
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
|-
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 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
| 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
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| 54 || 2025-11-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dupilumab
| 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
|}

Revision as of 22:42, 31 December 2025

FDA Oncology Approvals 2025
# Approval Date Medication (Brand) Company Indication Clinical Trial Name
1 2025-01-16 Sotorasib + Panitumumab (Lumakras + Vectibix) Amgen KRAS G12C–mutated metastatic colorectal cancer CodeBreaK 300
2 2025-01-16 Acalabrutinib + Bendamustine + Rituximab (Calquence) AstraZeneca Previously untreated mantle cell lymphoma ELEVATE-TN
3 2025-01-17 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo HR-positive, HER2-negative metastatic breast cancer TROPION-Breast01
4 2025-01-21 Treosulfan + Fludarabine (Grafapex) medac GmbH Conditioning for allogeneic HSCT in AML or MDS MC-FludT.14/L
5 2025-01-25 Epcoritamab-bysp (Epkinly) Genmab Relapsed or refractory follicular lymphoma EPCORE NHL-1
6 2025-01-30 Ziftomenib (Komzifti) Kura Oncology R/R AML with NPM1 mutation KOMET-001
7 2025-02-05 Mirdametinib (Gomekli) SpringWorks NF1-associated plexiform neurofibromas ReNeu
8 2025-02-12 Vimseltinib (Romvimza) Deciphera Tenosynovial giant cell tumor MOTION
9 2025-02-14 Pembrolizumab (Keytruda) Merck First-line unresectable pleural mesothelioma IND.227
10 2025-02-25 Durvalumab (Imfinzi) AstraZeneca Resectable non-small cell lung cancer AEGEAN
11 2025-03-05 Zanubrutinib (Brukinsa) BeiGene R/R follicular lymphoma with obinutuzumab ROSEWOOD
12 2025-03-12 Nivolumab (Opdivo) BMS First-line metastatic urothelial carcinoma CheckMate -901
13 2025-03-18 Mirvetuximab soravtansine-gynx (Elahere) ImmunoGen FRα-positive platinum-resistant ovarian cancer MIRASOL
14 2025-03-22 Ponatinib (Iclusig) Takeda Newly diagnosed Ph+ ALL PhALLCON
15 2025-04-02 Tislelizumab-jsgr (Tevimbra) BeiGene Metastatic esophageal squamous cell carcinoma RATIONALE-302
16 2025-04-05 Idecabtagene vicleucel (Abecma) BMS Relapsed/refractory multiple myeloma (earlier line) KarMMa-3
17 2025-04-10 Ciltacabtagene autoleucel (Carvykti) Janssen R/R multiple myeloma after one prior line CARTITUDE-4
18 2025-04-18 Fam-trastuzumab deruxtecan-nxki (Enhertu) Daiichi Sankyo HER2-low or HER2-ultralow metastatic breast cancer DESTINY-Breast06
19 2025-04-23 Lutathera Novartis Pediatric patients with GEP-NETs NETTER-P
20 2025-04-30 Tisotumab vedotin-tftv (Tivdak) Seagen Recurrent or metastatic cervical cancer innovaTV 301
21 2025-05-08 Selpercatinib (Retevmo) Eli Lilly Pediatric RET-altered medullary thyroid cancer LIBRETTO-121
22 2025-05-15 Tivozanib (Fotivda) AVEO R/R renal cell carcinoma with nivolumab TiNivo-2
23 2025-05-22 Amivantamab-vmjw (Rybrevant) Janssen NSCLC with EGFR Exon 20 insertion mutations PAPILLON
24 2025-05-30 Lisocabtagene maraleucel (Breyanzi) BMS Relapsed or refractory mantle cell lymphoma TRANSCEND MCL
25 2025-06-10 Selinexor (Xpovio) Karyopharm Recurrent or metastatic endometrial cancer SIENDO
26 2025-06-14 Blinatumomab (Blincyto) Amgen CD19-positive B-cell precursor ALL E1910
27 2025-06-21 Adagrasib (Krazati) BMS KRAS G12C-mutated colorectal cancer KRYSTAL-1
28 2025-06-27 Durvalumab (Imfinzi) AstraZeneca dMMR advanced or recurrent endometrial cancer DUO-E
29 2025-07-05 Pembrolizumab (Keytruda) Merck Primary advanced or recurrent endometrial cancer KEYNOTE-868
30 2025-07-12 Epcoritamab-bysp (Epkinly) Genmab R/R DLBCL after failure of CAR-T EPCORE NHL-1
31 2025-07-18 Belzutifan (Welireg) Merck Advanced renal cell carcinoma LITESPARK-005
32 2025-07-25 Vorasidenib (Voranigo) Servier Grade 2 astrocytoma or oligodendroglioma INDIGO
33 2025-08-01 Daratumumab + Hyaluronidase (Darzalex Faspro) Janssen Newly diagnosed multiple myeloma (transplant-eligible) PERSEUS
34 2025-08-08 Afatinib (Gilotrif) Boehringer Ingelheim Pediatric advanced solid tumors with ErbB mutations Study 1200.120
35 2025-08-15 Axicabtagene ciloleucel (Yescarta) Kite R/R indolent Non-Hodgkin Lymphoma ZUMA-5
36 2025-08-22 Lazertinib (Leclaza) Janssen First-line EGFR-mutated NSCLC MARIPOSA
37 2025-08-29 Inotuzumab ozogamicin (Besponsa) Pfizer Pediatric R/R B-cell precursor ALL Study B1931022
38 2025-09-05 Pembrolizumab (Keytruda) Merck First-line malignant pleural mesothelioma KEYNOTE-483
39 2025-09-12 Nivolumab (Opdivo) BMS Adjuvant resected ESCC CheckMate -577
40 2025-09-19 Zanubrutinib (Brukinsa) BeiGene Untreated CLL/SLL with venetoclax SEQUOIA
41 2025-09-26 Selpercatinib (Retevmo) Eli Lilly RET fusion-positive NSCLC LIBRETTO-431
42 2025-10-03 Entrectinib (Rozlytrek) Genentech Pediatric NTRK fusion-positive solid tumors STARTRK-NG
43 2025-10-10 Trametinib (Mekinist) Novartis Pediatric low-grade glioma with BRAF V600E Study G2201
44 2025-10-17 Pembrolizumab (Keytruda) Merck Advanced or metastatic biliary tract cancer KEYNOTE-966
45 2025-10-24 Lurbinectedin (Zepzelca) Jazz Pharma Relapsed small cell lung cancer LAGOON
46 2025-10-31 Fruquintinib (Fruzaqla) Takeda Refractory metastatic colorectal cancer FRESCO-2
47 2025-11-07 Capivasertib (Truqap) AstraZeneca HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations CAPItello-291
48 2025-11-14 Repotrectinib (Augtyro) BMS ROS1-positive metastatic NSCLC TRIDENT-1
49 2025-11-21 Nirogacestat (Ogsiveo) SpringWorks Progressing desmoid tumors DeFi
50 2025-11-25 Durvalumab (Imfinzi) AstraZeneca Resectable NSCLC (perioperative) AEGEAN
51 2025-12-05 Pirtobrutinib (Jaypirca) Eli Lilly R/R CLL/SLL after BTK and BCL-2 inhibitors BRUIN
52 2025-12-12 Belzutifan (Welireg) Merck Advanced clear cell renal cell carcinoma LITESPARK-005
53 2025-12-19 Tivozanib (Fotivda) AVEO Second-line renal cell carcinoma TiNivo-2
54 2025-12-28 Pembrolizumab (Keytruda) Merck First-line HER2-negative gastric cancer KEYNOTE-859
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