Https://www.neoplasm.org/wiki/Template:FDAApprovalRow
| 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