FDA Oncology Approvals 2025
| Item Number | Approval Date | Medication (Brand) | Company | Indication | Clinical Trial Name |
|---|---|---|---|---|---|
| 1 | 2025-01-16 | Sotorasib (Lumakras) Panitumumab (Vectibix) |
Amgen | KRAS G12C–mutated metastatic colorectal cancer | CodeBreK 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 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks | NF1-associated plexiform neurofibromas | ReNeu |
| 6 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera | Tenosynovial giant cell tumor | MOTION |
| 7 | 2025-02-14 | Pembrolizumab (Keytruda) | Merck | First-line metastatic pleural mesothelioma | IND.227 |
| 8 | 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-Met high non-squamous NSCLC | LUMINOSITY |
| 9 | 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | ROS1-positive metastatic NSCLC | TRUST-I |
| 10 | 2025-08-08 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutant metastatic NSCLC | Beamion LUNG-1 |
| 11 | 2025-10-24 | Revumenib (Revuforj) | Syndax | NPM1-mutant relapsed or refractory AML | AUGMENT-101 |
| 12 | 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | R/R AML with NPM1 mutation | KOMET-001 |
| 13 | 2025-12-03 | Pirtobrutinib (Jaypirca) | Eli Lilly | Traditional Approval: Relapsed or refractory CLL/SLL | BRUIN |
| 14 | 2025-12-12 | Niraparib (Akeega) Abiraterone acetate |
Janssen | BRCA2-mutated metastatic castration-sensitive prostate cancer | MAGNITUDE |
| 15 | 2025-12-17 | Amivantamab (Rybrevant Faspro) Hyaluronidase-lpuj |
Janssen | Subcutaneous formulation for NSCLC | PALOMA-3 |