FDA Oncology Approvals 2025: Difference between revisions
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[[Category:FDA approvals]] | |||
[[Category:Oncology]] | |||
Revision as of 17:30, 31 December 2025
| Approval date | Medication (Brand) | Company | Indication | Regulatory type | Trial(s) cited on FDA approval page |
|---|---|---|---|---|---|
| 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectibix) | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | Traditional approval | CodeBreaK 300 |
| 2025-01-16 | Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) | AstraZeneca | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT | Traditional approval | ELEVATE-TN |
| 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy | Accelerated approval | TROPION-Breast01 |
| 2025-01-21 | Treosulfan + Fludarabine (Grafapex) | medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | Traditional approval | MC-FludT.14/L Trial II |
| 2025-01-27 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | HR-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer | Traditional approval | DESTINY-Breast06 |
| 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks Therapeutics | Adult and pediatric patients ≥2 years with NF1-associated symptomatic plexiform neurofibromas | Traditional approval | ReNeu |
| 2025-02-11 | Brentuximab vedotin + Lenalidomide + Rituximab | Seagen (Pfizer) | Relapsed or refractory large B-cell lymphoma in patients ineligible for autologous HSCT or CAR-T therapy | Traditional approval | ECHELON-3 |
| 2025-02-14 | Vimseltinib (Romvimza) | Deciphera Pharmaceuticals | Tenosynovial giant cell tumor where surgical resection would cause severe morbidity | Traditional approval | MOTION |
| 2025-03-19 | Pembrolizumab + Trastuzumab + Chemotherapy | Merck | First-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma (PD-L1 CPS ≥1) | Traditional approval | KEYNOTE-811 |
| 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | Previously treated, unresectable or metastatic pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors | Traditional approval | CABINET |
| 2025-03-28 | Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) | Novartis | PSMA-positive metastatic castration-resistant prostate cancer | Traditional approval | PSMAfore |
| 2025-04-08 | Nivolumab + Ipilimumab | Bristol Myers Squibb | Unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer | Traditional approval | CheckMate-8HW |
| 2025-04-11 | Nivolumab + Ipilimumab | Bristol Myers Squibb | First-line treatment of unresectable or metastatic hepatocellular carcinoma | Traditional approval | CheckMate-9DW |
| 2025-04-23 | Penpulimab-kcqx | Akeso Biopharma | First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma | Traditional approval | AK105-304; AK105-202 |
| 2025-05-08 | Avutometinib + Defactinib | Verastem | KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy | Accelerated approval | RAMP-201 |
| 2025-05-14 | Belzutifan (Welireg) | Merck | Locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma | Traditional approval | LITESPARK-015 |
| 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-MET–overexpressing non-small cell lung cancer after prior systemic therapy | Accelerated approval | LUMINOSITY |
| 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Squamous cell carcinoma of the anal canal (first-line with chemotherapy or as monotherapy after platinum) | Traditional approval | POD1UM-303; POD1UM-202 |
| 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1-positive non-small cell lung cancer | Traditional approval | TRUST-I; TRUST-II |
| 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy | Accelerated approval | TROPION-Lung01; TROPION-Lung05 |
| 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal Pharma | EGFR exon 20 insertion NSCLC after platinum therapy | Accelerated approval | WU-KONG1 |
| 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed/refractory multiple myeloma (≥4 prior lines) | Accelerated approval | LINKER-MM1 |
| 2025-08-06 | Dordaviprone (Modeyso) | Jazz Pharmaceuticals | H3 K27M–mutant diffuse midline glioma | Accelerated approval | ACTION |
| 2025-08-08 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutated NSCLC after prior therapy | Accelerated approval | BEAMION-LUNG-1 |
| 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC with CIS | Traditional approval | SUNRISE-1 |
| 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+/HER2− metastatic breast cancer | Traditional approval | EMBER-3 |
| 2025-10-24 | Revumenib (Revuforj) | Syndax Pharmaceuticals | Relapsed/refractory NPM1-mutated AML | Accelerated approval | AUGMENT-101 |
| 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | Relapsed/refractory NPM1-mutated AML | Accelerated approval | KOMET-001 |
| 2025-11-18 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed/refractory follicular lymphoma | Traditional approval | EPCORE-NHL-1 |
| 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed/refractory marginal zone lymphoma | Traditional approval | TRANSCEND-NHL-001 |