FDA Oncology Approvals 2025

| class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |- | 1 || 2025-01-16 || Sotorasib (Lumakras)
Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 2 || 2025-01-16 || Acalabrutinib (Calquence)
Bendamustine
Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |- | 3 || 2025-01-17 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 4 || 2025-01-21 || Treosulfan (Grafapex)
Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || Amezalpat (TPST-1120) || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || Mirdametinib (Gomekli) || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || Vimseltinib (Romvimza) || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 2025-02-14 || Pembrolizumab (Keytruda) || Merck || First-line metastatic pleural mesothelioma || IND.227 |- | 9 || 2025-03-04 || Tislelizumab-jsgr (Tevimbra) || BeiGene || First-line PD-L1+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 2025-03-05 || Zanubrutinib (Brukinsa) || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |- | 11 || 2025-03-12 || Nivolumab (Opdivo) || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 |- | 12 || 2025-03-19 || Pembrolizumab (Keytruda) || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 |- | 13 || 2025-03-22 || Mirvetuximab soravtansine-gynx (Elahere) || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL |- | 14 || 2025-03-26 || Cabozantinib (Cabometyx) || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET |- | 15 || 2025-03-28 || 177Lu-PSMA-617 (Pluvicto) || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || Fitusiran (Qfitlia) || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || Atrasentan (Vanrafia) || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || Nivolumab (Opdivo)
Ipilimumab (Yervoy) || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || Bevacizumab-nwgdc (Jobevne) || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || Larotrectinib (Vitrakvi) || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 2025-04-10 || Ciltacabtagene autoleucel (Carvykti) || Janssen || R/R Multiple Myeloma (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || Nivolumab (Opdivo)
Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || Palonosetron (Posfrea) || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || Penpulimab-kcqx (Anike) || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || Palbociclib (Ibrance) || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || Nipocalimab-aahu (Imaavy) || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || Avutometinib
Defactinib (Avmapki Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 2025-05-08 || Selpercatinib (Retevmo) || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121 |- | 29 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY |- | 30 || 2025-05-14 || Belzutifan (Welireg) || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || Belzutifan (Welireg) || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 2025-05-30 || Lisocabtagene maraleucel (Breyanzi) || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL |- | 34 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 36 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || Talazoparib (Talzenna) || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || Mitomycin (Zusduri) || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || Tafasitamab-cxix (Monjuvi)
Lenalidomide
Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || Durvalumab (Imfinzi) || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1 |- | 44 || 2025-08-06 || Dordaviprone (Modeyso) || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 45 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || Leuprolide Mesylate (Camcevi) || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || Keytruda Qlex (Pembrolizumab subcutaneous) || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 53 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN |- | 54 || 2025-12-17 || Amivantamab (Rybrevant Faspro)
Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |}