FDA Oncology Approvals 2025: Difference between revisions
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! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name | ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name | ||
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| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated | | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 | ||
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| 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO | | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || ECHO | ||
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| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 | | 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 | ||
Revision as of 02:08, 1 January 2026
| # | Approval Date | Medication (Brand Name) | Company | Indication | Clinical Trial Name |
|---|---|---|---|---|---|
| 1 | 2025-01-16 | Sotorasib (Lumakras) Panitumumab (Vectibix) |
Amgen | KRAS G12C–mutated metastatic colorectal cancer | CodeBreaK 300 |
| 2 | 2025-01-16 | Acalabrutinib (Calquence) | AstraZeneca | Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) | 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) | medac GmbH | Conditioning for alloHSCT in AML or MDS | MC-FludT.14/L |
| 5 | 2025-01-27 | Fam-trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-low or HER2-ultralow metastatic breast cancer | DESTINY-Breast06 |
| 6 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks | NF1-associated plexiform neurofibromas | ReNeu |
| 7 | 2025-02-11 | Brentuximab vedotin (Adcetris) | Pfizer | Relapsed or refractory large B-cell lymphoma | ECHELON-3 |
| 8 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera | Tenosynovial giant cell tumor (TGCT) | MOTION |
| 9 | 2025-03-04 | Tislelizumab-jsgr (Tevimbra) | BeiGene | First-line esophageal squamous cell carcinoma | RATIONALE-306 |
| 10 | 2025-03-05 | Zanubrutinib (Brukinsa) | BeiGene | Relapsed or refractory follicular lymphoma (FL) | ROSEWOOD |
| 11 | 2025-03-07 | Dabrafenib (Tafinlar) | Novartis | Pediatric BRAF-mutant melanoma | N/A |
| 12 | 2025-03-12 | Nivolumab (Opdivo) | BMS | First-line metastatic urothelial carcinoma | CheckMate-901 |
| 13 | 2025-03-12 | Binimetinib (Mektovi) | Pfizer | Metastatic NSCLC | N/A |
| 14 | 2025-03-12 | Encorafenib (Braftovi) | Pfizer | Metastatic NSCLC | N/A |
| 15 | 2025-03-19 | Pembrolizumab (Keytruda) | Merck | HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma | KEYNOTE-811 |
| 16 | 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | pNET and epNET indications | CABINET |
| 17 | 2025-03-28 | Lutetium Lu 177 (Pluvicto) | Novartis | PSMA-positive metastatic mCRPC (Earlier use) | PSMAfore |
| 18 | 2025-03-28 | Durvalumab (Imfinzi) | AstraZeneca | Neoadjuvant/adjuvant muscle invasive bladder cancer | NIAGARA |
| 19 | 2025-04-08 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
BMS | MSI-H or dMMR metastatic colorectal cancer | CheckMate-8HW |
| 20 | 2025-04-09 | Bevacizumab-nwgdc (Jobevne) | Biocon Biologics | Biosimilar for various cancer indications | N/A |
| 21 | 2025-04-09 | Larotrectinib (Vitrakvi) | Bayer | NTRK gene fusion solid tumors | NAVIGATE |
| 22 | 2025-04-11 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
BMS | First-line unresectable or metastatic HCC | CheckMate-9DW |
| 23 | 2025-04-23 | Penpulimab-kcqx (Anike) | Akeso | First-line non-keratinizing nasopharyngeal carcinoma | AK105-302 |
| 24 | 2025-04-23 | Palbociclib (Ibrance) | Pfizer | Expanded indications for breast cancer | PALOMA-2 |
| 25 | 2025-05-08 | Avutometinib Defactinib (Fakzynja) |
Verastem | KRAS-mutated recurrent LGSOC | RAMP 201 |
| 26 | 2025-05-08 | Selpercatinib (Retevmo) | Eli Lilly | Pediatric RET-altered medullary thyroid cancer | LIBRETTO-121 |
| 27 | 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-Met high metastatic non-squamous NSCLC | LUMINOSITY |
| 28 | 2025-05-14 | Belzutifan (Welireg) | Merck | Pheochromocytoma or paraganglioma (PPGL) | LITESPARK-013 |
| 29 | 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Squamous cell anal carcinoma | POD1UM-303 |
| 30 | 2025-05-30 | Lisocabtagene maraleucel (Breyanzi) | BMS | Relapsed or refractory mantle cell lymphoma | TRANSCEND MCL |
| 31 | 2025-06-03 | Darolutamide (Nubeqa) | Bayer | Metastatic castration-sensitive prostate cancer | ARANOTE |
| 32 | 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1-positive NSCLC | TRUST-I |
| 33 | 2025-06-12 | Pembrolizumab (Keytruda) | Merck | Resectable locally advanced HNSCC | KEYNOTE-689 |
| 34 | 2025-06-12 | Mitomycin (Zusduri) | UroGen | Recurrent low-grade intermediate-risk NMIBC | ENVISION |
| 35 | 2025-06-18 | Tafasitamab-cxix (Monjuvi) | Incyte | Relapsed or refractory follicular lymphoma (FL) | inMIND |
| 36 | 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated metastatic NSCLC | TROPION-LUNG01 |
| 37 | 2025-06-27 | Durvalumab (Imfinzi) | AstraZeneca | dMMR advanced or recurrent endometrial cancer | DUO-E |
| 38 | 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal | EGFR Exon 20 insertion mutant NSCLC | WU-KONG6 |
| 39 | 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed or refractory multiple myeloma | LINKER-MM1 |
| 40 | 2025-08-06 | Dordaviprone (Modeyso) | Jazz | H3 K27M-mutated progressive diffuse midline glioma | ONC201 |
| 41 | 2025-08-08 | Zongertinib (Hernexeos) | Boehringer | Non-squamous NSCLC with HER2 TKD mutations | Beamion LUNG-1 |
| 42 | 2025-08-25 | Leuprolide mesylate (Camcevi) | Tolmar | Advanced prostate cancer (3-month formulation) | FP-001 LMIS |
| 43 | 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC | N/A |
| 44 | 2025-09-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric NF1 with symptomatic plexiform neurofibromas | SPRINT |
| 45 | 2025-09-19 | Pembrolizumab subcutaneous (Keytruda Qlex) | Merck | Subcutaneous solid tumor indications | MK-3475-A86 |
| 46 | 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ER+, HER2-, ESR1-mutated advanced breast cancer | EMBER-3 |
| 47 | 2025-10-02 | Lurbinectedin (Zepzelca) | Jazz | ES-SCLC maintenance | IMforte |
| 48 | 2025-10-08 | Cemiplimab-rwlc (Libtayo) | Regeneron | Adjuvant cutaneous squamous cell carcinoma | C-POST |
| 49 | 2025-10-23 | Belantamab mafodotin-blmf (Blenrep) | GSK | Relapsed or refractory multiple myeloma | DREAMM-7 |
| 50 | 2025-11-06 | Daratumumab subcutaneous (Darzalex Faspro) | Janssen | High-risk smoldering multiple myeloma | AQUILA |
| 51 | 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | R/R AML with susceptible NPM1 mutation | KOMET-001 |
| 52 | 2025-12-03 | Pirtobrutinib (Jaypirca) | Eli Lilly | R/R CLL or SLL (Traditional Approval) | BRUIN |
| 53 | 2025-12-17 | Amivantamab subcutaneous (Rybrevant Faspro) | Janssen | Subcutaneous delivery for all indications | PALOMA-3 |