FDA Oncology Approvals 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) | AstraZeneca | Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) | 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) | medac GmbH | Conditioning for alloHSCT in AML or MDS | MC-FludT.14/L |
| 5 | 2025-01-27 | Fam-trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-low or -ultralow metastatic breast cancer | DESTINY-Breast06 |
| 6 | 2025-02-10 | Amezalpat (TPST-1120) | Tempest | First-line unresectable or metastatic HCC | Phase 1b/2 Study |
| 7 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks | NF1-associated plexiform neurofibromas | ReNeu |
| 8 | 2025-02-11 | Brentuximab vedotin (Adcetris) | Seagen/Pfizer | Relapsed or refractory large B-cell lymphoma | ECHELON-3 |
| 9 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera | Symptomatic tenosynovial giant cell tumor | MOTION |
| 10 | 2025-03-04 | Tislelizumab-jsgr (Tevimbra) | BeiGene | First-line esophageal squamous cell carcinoma | RATIONALE-306 |
| 11 | 2025-03-05 | Zanubrutinib (Brukinsa) | BeiGene | Relapsed or refractory follicular lymphoma | ROSEWOOD |
| 12 | 2025-03-12 | Nivolumab (Opdivo) | BMS | First-line metastatic urothelial carcinoma | CheckMate-901 |
| 13 | 2025-03-19 | Pembrolizumab (Keytruda) | Merck | HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma | KEYNOTE-811 |
| 14 | 2025-03-22 | Mirvetuximab soravtansine-gynx (Elahere) | ImmunoGen | FRα-positive, platinum-resistant ovarian cancer | MIRASOL |
| 15 | 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | pNET and epNET indications | CABINET |
| 16 | 2025-03-28 | Lutetium Lu 177 (Pluvicto) | Novartis | PSMA+ mCRPC (Pre-taxane) | PSMAfore |
| 17 | 2025-03-28 | Durvalumab (Imfinzi) | AstraZeneca | Neoadjuvant/adjuvant muscle invasive bladder cancer | NIAGARA |
| 18 | 2025-04-08 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
BMS | MSI-H or dMMR metastatic colorectal cancer | CheckMate-8HW |
| 19 | 2025-04-10 | Ciltacabtagene autoleucel (Carvykti) | Janssen | R/R Multiple Myeloma after one prior line | CARTITUDE-4 |
| 20 | 2025-04-11 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
BMS | First-line unresectable/metastatic HCC | CheckMate-9DW |
| 21 | 2025-04-23 | Penpulimab-kcqx | Akeso | First-line non-keratinizing nasopharyngeal carcinoma | AK105-302 |
| 22 | 2025-05-08 | Avutometinib Defactinib (Fakzynja) |
Verastem | KRAS-mutated recurrent LGSOC | RAMP 201 |
| 23 | 2025-05-08 | Selpercatinib (Retevmo) | Eli Lilly | Pediatric RET-altered medullary thyroid cancer / RET-fusion thyroid cancer / RET-fusion solid tumors | LIBRETTO-121 |
| 24 | 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-Met high non-squamous metastatic NSCLC | LUMINOSITY |
| 25 | 2025-05-14 | Belzutifan (Welireg) | Merck | Pheochromocytoma or paraganglioma | LITESPARK-013 |
| 26 | 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Metastatic squamous cell carcinoma of anal canal | POD1UM-303 |
| 27 | 2025-05-30 | Lisocabtagene maraleucel (Breyanzi) | BMS | Relapsed or refractory Mantle Cell Lymphoma | TRANSCEND MCL |
| 28 | 2025-06-03 | Darolutamide (Nubeqa) | Bayer | Metastatic castration-sensitive prostate cancer | ARANOTE |
| 29 | 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1+ NSCLC | TRUST-I |
| 30 | 2025-06-12 | Pembrolizumab (Keytruda) | Merck | Resectable locally advanced HNSCC | KEYNOTE-689 |
| 31 | 2025-06-12 | Mitomycin intravesical (Zusduri) | UroGen | Recurrent LG-IR-NMIBC | ENVISION |
| 32 | 2025-06-18 | Tafasitamab-cxix (Monjuvi) | Incyte | Relapsed or refractory Follicular Lymphoma | inMIND |
| 33 | 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated metastatic NSCLC | TROPION-LUNG01 |
| 34 | 2025-06-27 | Durvalumab (Imfinzi) | AstraZeneca | dMMR advanced or recurrent endometrial cancer | DUO-E |
| 35 | 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal | EGFR Exon 20 insertion mutant NSCLC | WU-KONG6 |
| 36 | 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed or refractory Multiple Myeloma | LINKER-MM1 |
| 37 | 2025-08-06 | Dordaviprone (Modeyso) | Jazz | H3 K27M-mutated progressive midline glioma | ONC201 |
| 38 | 2025-08-08 | Zongertinib (Hernexeos) | Boehringer | Non-squamous NSCLC with HER2 TKD mutations | Beamion LUNG-1 |
| 39 | 2025-08-25 | Leuprolide mesylate (Camcevi ETM) | Tolmar | Advanced prostate cancer (3-month injection) | FP-001 LMIS |
| 40 | 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC | Bridge |
| 41 | 2025-09-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric NF1 with symptomatic plexiform neurofibromas | SPRINT |
| 42 | 2025-09-19 | Pembrolizumab subcutaneous (Keytruda Qlex) | Merck | Subcutaneous solid tumor indications | MK-3475-A86 |
| 43 | 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+/HER2- breast cancer | EMBER-3 |
| 44 | 2025-10-02 | Lurbinectedin (Zepzelca) | Jazz | ES-SCLC maintenance (with atezolizumab) | IMforte |
| 45 | 2025-10-08 | Cemiplimab-rwlc (Libtayo) | Regeneron | Adjuvant cutaneous squamous cell carcinoma | C-POST |
| 46 | 2025-10-23 | Belantamab mafodotin-blmf (Blenrep) | GSK | Relapsed or refractory Multiple Myeloma | DREAMM-7 |
| 47 | 2025-10-24 | Revumenib (Revuforj) | Syndax | NPM1-mutant relapsed or refractory AML | AUGMENT-101 |
| 48 | 2025-11-06 | Daratumumab subcutaneous (Darzalex Faspro) | Janssen | High-risk smoldering multiple myeloma | AQUILA |
| 49 | 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | R/R AML with susceptible NPM1 mutation | KOMET-001 |
| 50 | 2025-11-19 | Tarlatamab-dlle (Imdelltra) | Amgen | Extensive stage SCLC (Traditional Approval) | DeLLphi-301 |
| 51 | 2025-11-25 | Durvalumab (Imfinzi) | AstraZeneca | Resectable gastric or GEJ adenocarcinoma | MATTERHORN |
| 52 | 2025-12-03 | Pirtobrutinib (Jaypirca) | Eli Lilly | R/R CLL or SLL (Traditional Approval) | BRUIN |
| 53 | 2025-12-17 | Amivantamab subcutaneous (Rybrevant Faspro) | Janssen | Subcutaneous delivery for all indications | PALOMA-3 |