FDA Oncology Approvals 2025
| # | Approval Date | Medication (Brand Name) | Company | Indication | Clinical Trial Name |
|---|---|---|---|---|---|
| 1 | 2025-01-16 | Acalabrutinib (Calquence) | AstraZeneca | Previously untreated mantle cell lymphoma (with bendamustine and rituximab) | ECHO |
| 2 | 2025-01-16 | Sotorasib (Lumakras) Panitumumab (Vectibix) |
Amgen | KRAS G12C–mutated metastatic colorectal cancer | CodeBreaK 300 |
| 3 | 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | Unresectable or metastatic HR-positive, HER2-negative breast cancer | TROPION-Breast01 |
| 4 | 2025-01-21 | Treosulfan (Grafapex) | medac GmbH | Preparative regimen with fludarabine for alloHSCT in AML or MDS | MC-FludT.14/L |
| 5 | 2025-01-27 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer | DESTINY-Breast06 |
| 6 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks Therapeutics | NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) | ReNeu |
| 7 | 2025-02-12 | Brentuximab vedotin (Adcetris) | Pfizer | Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) | ECHELON-3 |
| 8 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera Pharmaceuticals | Symptomatic tenosynovial giant cell tumor (TGCT) | MOTION |
| 9 | 2025-03-19 | Pembrolizumab (Keytruda) | Merck | HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) | KEYNOTE-811 |
| 10 | 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) | CABINET |
| 11 | 2025-03-28 | Durvalumab (Imfinzi) | AstraZeneca | Muscle invasive bladder cancer (neoadjuvant + adjuvant) | NIAGARA |
| 12 | 2025-03-28 | Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) | Novartis | PSMA-positive mCRPC (expanded indication, earlier-line) | PSMAfore |
| 13 | 2025-04-08 | [https://www.fda.gov/drugs/resources-information-approved |