FDA Oncology Approvals 2025: Difference between revisions
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| Accelerated approval | | Accelerated approval | ||
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Beamion LUNG-1] | | [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Beamion LUNG-1] | ||
|- | |||
| 2025-09-25 | |||
| Imlunestrant (Inluriiyo) | |||
| Eli Lilly | |||
| ESR1-mutated ER+/HER2– metastatic breast cancer | |||
| Traditional approval | |||
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-esr1-mutated-metastatic-breast-cancer EMBER-3] | |||
|- | |||
| 2025-10-24 | |||
| Revumenib (Revuforj) | |||
| Syndax Pharmaceuticals | |||
| Relapsed or refractory NPM1-mutated acute myeloid leukemia | |||
| Accelerated approval | |||
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-revumenib-npm1-mutated-acute-myeloid-leukemia AUGMENT-101] | |||
|- | |||
| 2025-11-13 | |||
| Ziftomenib (Komzifti) | |||
| Kura Oncology | |||
| Relapsed or refractory NPM1-mutated acute myeloid leukemia | |||
| Accelerated approval | |||
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ziftomenib-npm1-mutated-acute-myeloid-leukemia KOMET-001] | |||
|- | |||
| 2025-11-18 | |||
| Epcoritamab-bysp (Epkinly) | |||
| Genmab | |||
| Relapsed or refractory follicular lymphoma | |||
| Traditional approval | |||
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-relapsed-or-refractory-follicular-lymphoma EPCORE-NHL-1] | |||
|- | |- | ||
| 2025-12-03 | | 2025-12-03 | ||
Revision as of 20:40, 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 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 |
| 2025-01-30 | Treosulfan + Fludarabine (Grafapex) |
Medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | Traditional approval | MC-FludT.14/L |
| 2025-02-11 | Mirdametinib (Gomekli) |
SpringWorks Therapeutics | Adults and children ≥2 years with NF1-associated plexiform neurofibromas | Traditional approval | ReNeu |
| 2025-02-14 | Brentuximab vedotin + Lenalidomide + Rituximab | Seagen / Bristol Myers Squibb | Relapsed or refractory diffuse large B-cell lymphoma | Traditional approval | ECHELON-3 |
| 2025-03-05 | Pembrolizumab + Trastuzumab + Chemotherapy | Merck & Co. | HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma | Traditional approval | KEYNOTE-811 |
| 2025-03-14 | Cabozantinib (Cabometyx) |
Exelixis | Previously treated metastatic pancreatic neuroendocrine tumors | Traditional approval | CABINET |
| 2025-04-08 | Nivolumab + Ipilimumab | Bristol Myers Squibb | MSI-H or dMMR metastatic colorectal cancer | Traditional approval | CheckMate-8HW |
| 2025-05-02 | Avutometinib + Defactinib | Verastem Oncology | KRAS-mutated recurrent low-grade serous ovarian cancer | Accelerated approval | RAMP-201 |
| 2025-05-14 | Belzutifan (Welireg) |
Merck & Co. | Advanced sporadic clear cell renal cell carcinoma | Traditional approval | LITESPARK-005 |
| 2025-06-13 | Datopotamab deruxtecan-dlnk (Datroway) |
Daiichi Sankyo | EGFR-mutated locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum chemotherapy | Accelerated approval | TROPION-Lung01 TROPION-Lung05 |
| 2025-07-02 | Sunvozertinib (Zegfrovy) |
Dizal Pharma | EGFR exon 20 insertion–mutated metastatic NSCLC after platinum chemotherapy | Accelerated approval | WU-KONG1B |
| 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) |
Regeneron Pharmaceuticals | Relapsed or refractory multiple myeloma after ≥4 prior lines of therapy | Accelerated approval | LINKER-MM1 |
| 2025-08-08 | Zongertinib (Hernexeos) |
Boehringer Ingelheim | HER2-mutated non-squamous NSCLC after prior systemic therapy | Accelerated approval | Beamion LUNG-1 |
| 2025-09-25 | Imlunestrant (Inluriiyo) | Eli Lilly | ESR1-mutated ER+/HER2– metastatic breast cancer | Traditional approval | EMBER-3 |
| 2025-10-24 | Revumenib (Revuforj) | Syndax Pharmaceuticals | Relapsed or refractory NPM1-mutated acute myeloid leukemia | Accelerated approval | AUGMENT-101 |
| 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | Relapsed or refractory NPM1-mutated acute myeloid leukemia | Accelerated approval | KOMET-001 |
| 2025-11-18 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed or refractory follicular lymphoma | Traditional approval | EPCORE-NHL-1 |
| 2025-12-03 | Pirtobrutinib (Jaypirca) |
Eli Lilly and Company | Relapsed or refractory CLL/SLL after prior covalent BTK inhibitor | Traditional approval | BRUIN-CLL-321 |
| 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) |
Bristol Myers Squibb | Relapsed or refractory marginal zone lymphoma after ≥2 prior therapies | Traditional approval | TRANSCEND FL-MZL |
| 2025-12-12 | Niraparib + Abiraterone acetate + Prednisone (Akeega) |
Janssen Biotech | BRCA2-mutated metastatic castration-sensitive prostate cancer | Traditional approval | AMPLITUDE |