FDA Oncology Approvals 2025
| Approval date | Medication | Drug class / property | Company | Indication | Regulatory type | Key trial(s) | Reference |
|---|---|---|---|---|---|---|---|
| 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectibix) |
KRAS G12C inhibitor + EGFR monoclonal antibody | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior chemotherapy | Traditional | CodeBreaK 300 | Reference |
| 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) |
TROP2 antibody–drug conjugate | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer | Accelerated approval | TROPION-Breast01 | Reference |
| 2025-03-26 | Cabozantinib (Cabometyx) |
Multikinase inhibitor | Exelixis | Previously treated pancreatic and extra-pancreatic neuroendocrine tumors | Traditional | CABINET | Reference |
| 2025-05-08 | Avutometinib + Defactinib | RAF/MEK inhibitor + FAK inhibitor | Verastem | KRAS-mutated recurrent low-grade serous ovarian cancer | Accelerated approval | RAMP-201 | Reference |
| 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) |
TROP2 antibody–drug conjugate | Daiichi Sankyo | EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy | Accelerated approval | Reference | |
| 2025-07-02 | Sunvozertinib (Zegfrovy) | Kinase inhibitor | Dizal Pharma | EGFR exon 20 insertion NSCLC after platinum therapy | Accelerated approval | WU-KONG1B | Reference |
| 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | BCMA × CD3 bispecific antibody | Regeneron Pharmaceuticals | Relapsed/refractory multiple myeloma (≥4 prior lines) | Accelerated approval | LINKER-MM1 | Reference |
| 2025-08-06 | Dordaviprone (Modeyso) | Small-molecule protease activator | Jazz Pharmaceuticals | H3 K27M–mutant diffuse midline glioma after prior therapy | Accelerated approval | ONC006 ONC013 ONC014 ONC016 ONC018 |
Reference |
| 2025-08-08 | Zongertinib (Hernexeos) | Kinase inhibitor | Boehringer Ingelheim | HER2 (ERBB2) TKD-mutant non-squamous NSCLC after prior systemic therapy | Accelerated approval | Beamion%20LUNG-1 | Reference |
| 2025-12-03 | Pirtobrutinib (Jaypirca) | Non-covalent (reversible) BTK inhibitor | Eli Lilly and Company | Relapsed/refractory CLL/SLL after prior covalent BTK inhibitor | Traditional approval | BRUIN-CLL-321 | Reference |
| 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) | CD19-directed CAR T-cell therapy | Bristol Myers Squibb (Juno Therapeutics) | Relapsed/refractory marginal zone lymphoma after ≥2 prior systemic therapies | Traditional approval | TRANSCEND%20FL-MZL | Reference |
| 2025-12-12 | Niraparib + abiraterone acetate + prednisone (Akeega) | PARP inhibitor + androgen biosynthesis inhibitor | Janssen Biotech, Inc. | BRCA2-mutated metastatic castration-sensitive prostate cancer | Traditional approval | AMPLITUDE | Reference |