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 | ELEVATE-TN |
| 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 | 2025-01-25 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed or refractory follicular lymphoma | EPCORE NHL-1 |
| 6 | 2025-01-30 | Ziftomenib (Komzifti) | Kura Oncology | R/R AML with NPM1 mutation | KOMET-001 |
| 7 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks | NF1-associated plexiform neurofibromas | ReNeu |
| 8 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera | Tenosynovial giant cell tumor | MOTION |
| 9 | 2025-02-14 | Pembrolizumab (Keytruda) | Merck | First-line unresectable pleural mesothelioma | IND.227 |
| 10 | 2025-02-25 | Durvalumab (Imfinzi) | AstraZeneca | Resectable non-small cell lung cancer | AEGEAN |
| 11 | 2025-03-05 | Zanubrutinib (Brukinsa) | BeiGene | R/R follicular lymphoma with obinutuzumab | ROSEWOOD |
| 12 | 2025-03-12 | Nivolumab (Opdivo) | BMS | First-line metastatic urothelial carcinoma | CheckMate -901 |
| 13 | 2025-03-18 | Mirvetuximab soravtansine-gynx (Elahere) | ImmunoGen | FRα-positive platinum-resistant ovarian cancer | MIRASOL |
| 14 | 2025-03-22 | Ponatinib (Iclusig) | Takeda | Newly diagnosed Ph+ ALL | PhALLCON |
| 15 | 2025-04-02 | Tislelizumab-jsgr (Tevimbra) | BeiGene | Metastatic esophageal squamous cell carcinoma | RATIONALE-302 |
| 16 | 2025-04-05 | Idecabtagene vicleucel (Abecma) | BMS | Relapsed/refractory multiple myeloma | KarMMa-3 |
| 17 | 2025-04-10 | Ciltacabtagene autoleucel (Carvykti) | Janssen | R/R multiple myeloma after one prior line | CARTITUDE-4 |
| 18 | 2025-04-18 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | HER2-low metastatic breast cancer | DESTINY-Breast06 |
| 19 | 2025-04-23 | Lutathera | Novartis | Pediatric GEP-NETs | NETTER-P |
| 20 | 2025-04-30 | Tisotumab vedotin-tftv (Tivdak) | Seagen | Recurrent or metastatic cervical cancer | innovaTV 301 |
| 21 | 2025-05-08 | Selpercatinib (Retevmo) | Eli Lilly | Pediatric RET-altered medullary thyroid cancer | LIBRETTO-121 |
| 22 | 2025-05-15 | Tivozanib (Fotivda) | AVEO | R/R renal cell carcinoma | TiNivo-2 |
| 23 | 2025-05-22 | Amivantamab-vmjw (Rybrevant) | Janssen | NSCLC with EGFR Exon 20 insertion mutations | PAPILLON |
| 24 | 2025-05-30 | Lisocabtagene maraleucel (Breyanzi) | BMS | R/R mantle cell lymphoma | TRANSCEND MCL |
| 25 | 2025-06-10 | Selinexor (Xpovio) | Karyopharm | Recurrent or metastatic endometrial cancer | SIENDO |
| 26 | 2025-06-14 | Blinatumomab (Blincyto) | Amgen | CD19-positive B-cell precursor ALL | E1910 |
| 27 | 2025-06-21 | Adagrasib (Krazati) | BMS | KRAS G12C-mutated colorectal cancer | KRYSTAL-1 |
| 28 | 2025-06-27 | Durvalumab (Imfinzi) | AstraZeneca | dMMR advanced endometrial cancer | DUO-E |
| 29 | 2025-07-05 | Pembrolizumab (Keytruda) | Merck | Primary advanced endometrial cancer | KEYNOTE-868 |
| 30 | 2025-07-12 | Epcoritamab-bysp (Epkinly) | Genmab | R/R DLBCL | EPCORE NHL-1 |
| 31 | 2025-07-18 | Belzutifan (Welireg) | Merck | Advanced renal cell carcinoma | LITESPARK-005 |
| 32 | 2025-07-25 | Vorasidenib (Voranigo) | Servier | Grade 2 astrocytoma | INDIGO |
| 33 | 2025-08-01 | [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-hyaluronidase-fihj-combination-bortezomib-lenalidomide-and-dexamethasone Daratumumab + Hyaluronidase | Janssen | Newly diagnosed multiple myeloma | PERSEUS |
| 34 | 2025-08-08 | Afatinib (Gilotrif) | Boehringer Ingelheim | Pediatric solid tumors with ErbB mutations | Study 1200.120 |
| 35 | 2025-08-15 | Axicabtagene ciloleucel (Yescarta) | Kite | R/R indolent NHL | ZUMA-5 |
| 36 | 2025-08-22 | Lazertinib (Leclaza) | Janssen | First-line EGFR-mutated NSCLC | MARIPOSA |
| 37 | 2025-08-29 | Inotuzumab ozogamicin (Besponsa) | Pfizer | Pediatric R/R B-cell ALL | Study B1931022 |
| 38 | 2025-09-05 | Pembrolizumab (Keytruda) | Merck | First-line malignant pleural mesothelioma | KEYNOTE-483 |
| 39 | 2025-09-12 | Nivolumab (Opdivo) | BMS | Adjuvant resected ESCC | CheckMate -577 |
| 40 | 2025-09-19 | Zanubrutinib (Brukinsa) | BeiGene | Untreated CLL/SLL with venetoclax | SEQUOIA |
| 41 | 2025-09-26 | Selpercatinib (Retevmo) | Eli Lilly | RET fusion-positive NSCLC | LIBRETTO-431 |
| 42 | 2025-10-03 | Entrectinib (Rozlytrek) | Genentech | Pediatric NTRK+ solid tumors | STARTRK-NG |
| 43 | 2025-10-10 | Trametinib (Mekinist) | Novartis | Pediatric low-grade glioma with BRAF V600E | Study G2201 |
| 44 | 2025-10-17 | Pembrolizumab (Keytruda) | Merck | Advanced biliary tract cancer | KEYNOTE-966 |
| 45 | 2025-10-24 | Lurbinectedin (Zepzelca) | Jazz Pharma | Relapsed small cell lung cancer | LAGOON |
| 46 | 2025-10-31 | Fruquintinib (Fruzaqla) | Takeda | Refractory metastatic colorectal cancer | FRESCO-2 |
| 47 | 2025-11-07 | Capivasertib (Truqap) | AstraZeneca | HR+/HER2- breast cancer | CAPItello-291 |
| 48 | 2025-11-14 | Repotrectinib (Augtyro) | BMS | ROS1-positive metastatic NSCLC | TRIDENT-1 |
| 49 | 2025-11-21 | Nirogacestat (Ogsiveo) | SpringWorks | Progressing desmoid tumors | DeFi |
| 50 | 2025-11-25 | Durvalumab (Imfinzi) | AstraZeneca | Resectable gastric cancer | AEGEAN |
| 51 | 2025-12-03 | Pirtobrutinib (Jaypirca) | Eli Lilly | Traditional Approval: R/R CLL/SLL | BRUIN |
| 52 | 2025-12-12 | Belzutifan (Welireg) | Merck | Advanced clear cell RCC | LITESPARK-005 |
| 53 | 2025-12-19 |