FDA Oncology Approvals 2025: Difference between revisions
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| 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT | | 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT | ||
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| 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications || | | 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77 | ||
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| 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3 | | 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3 | ||
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| 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001 | | 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001 | ||
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| 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || | | 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies | ||
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| 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1 | | 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1 | ||
Revision as of 10:55, 1 January 2026
| # | 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 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
Bristol Myers Squibb | Unresectable or metastatic MSI-H or dMMR colorectal cancer | CheckMate-8HW |
| 14 | 2025-04-11 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
Bristol Myers Squibb | Unresectable or metastatic hepatocellular carcinoma (first-line) | CheckMate 9DW |
| 15 | 2025-04-23 | Penpulimab-kcqx | Akeso Biopharma | Non-keratinizing nasopharyngeal carcinoma (first-line) | AK105-304 |
| 16 | 2025-05-08 | Avutometinib + Defactinib | Verastem | KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) | RAMP 201 |
| 17 | 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | NSCLC with high c-Met overexpression (accelerated) | LUMINOSITY |
| 18 | 2025-05-14 | Belzutifan (Welireg) | Merck | Pheochromocytoma or paraganglioma | LITESPARK-016 |
| 19 | 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Squamous cell carcinoma of the anal canal (combo + monotherapy) | POD1UM-303 |
| 20 | 2025-06-03 | Darolutamide (Nubeqa) | Bayer | Metastatic castration-sensitive prostate cancer (expanded) | ARANOTE |
| 21 | 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | ROS1-positive NSCLC | TRUST-II |
| 22 | 2025-06-12 | Pembrolizumab (Keytruda) | Merck | Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) | KEYNOTE-689 |
| 23 | 2025-06-12 | Mitomycin intravesical solution (Zusduri) | UroGen Pharma | Recurrent low-grade intermediate-risk NMIBC | ENVISION |
| 24 | 2025-06-18 | Tafasitamab-cxix (Monjuvi) | Incyte | Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) | inMIND |
| 25 | 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated locally advanced or metastatic NSCLC (accelerated) | TROPION-Lung01 / TROPION-Lung05 |
| 26 | 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal Pharmaceutical | EGFR exon 20 insertion mutated NSCLC (accelerated) | WU-KONG1B |
| 27 | 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) | LINKER-MM1 |
| 28 | 2025-08-06 | Dordaviprone (Modeyso) | Jazz Pharmaceuticals | Diffuse midline glioma (H3 K27M-mutated, accelerated) | Integrated (ONC006/013/014/016/018) |
| 29 | 2025-08-08 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutated non-squamous NSCLC (accelerated) | Beamion LUNG-1 |
| 30 | 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC with CIS | SunRISe-1 |
| 31 | 2025-09-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) | SPRINT |
| 32 | 2025-09-19 | Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) | Merck | Subcutaneous formulation across approved solid tumor indications | MK-3475A-D77 |
| 33 | 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+/HER2− advanced or metastatic breast cancer | EMBER-3 |
| 34 | 2025-10-02 | Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) | Jazz / Genentech | Maintenance in extensive-stage small cell lung cancer | IMforte |
| 35 | 2025-10-08 | Cemiplimab-rwlc (Libtayo) | Regeneron | Adjuvant cutaneous squamous cell carcinoma (high-risk) | C-POST |
| 36 | 2025-10-23 | Belantamab mafodotin-blmf (Blenrep) | GlaxoSmithKline | Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) | DREAMM-7 / DREAMM-8 |
| 37 | 2025-10-24 | Revumenib (Revuforj) | Syndax | NPM1-mutated relapsed or refractory AML (adult & pediatric ≥1 year) | AUGMENT-101 |
| 38 | 2025-11-06 | Daratumumab and hyaluronidase-fihj (Darzalex Faspro) | Janssen | High-risk smoldering multiple myeloma | AQUILA |
| 39 | 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | NPM1-mutated relapsed or refractory AML | KOMET-001 |
| 40 | 2025-11-13 | Pertuzumab-dpzb (Poherdy) | Shanghai Henlius Biologics | Interchangeable biosimilar to Perjeta | Biosimilarity studies |
| 41 | 2025-11-18 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed or refractory follicular lymphoma (combo + monotherapy) | EPCORE FL-1 |
| 42 | 2025-11-19 | Selumetinib (Koselugo) | AstraZeneca | Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas | SPRINT |
| 43 | 2025-11-19 | Daratumumab and hyaluronidase-fihj (Darzalex Faspro) | Janssen | Newly diagnosed light chain amyloidosis (traditional approval) | ANDROMEDA |
| 44 | 2025-11-19 | Sevabertinib (Hyrnuo) | Bayer | HER2-mutated non-squamous NSCLC (accelerated) | SOHO-01 |
| 45 | 2025-11-19 | Tarlatamab-dlle (Imdelltra) | Amgen | Extensive-stage small cell lung cancer (traditional approval) | DeLLphi-301 |
| 46 | 2025-11-21 | Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) | Merck / Astellas | Muscle invasive bladder cancer (cisplatin-ineligible) | KEYNOTE-A39 / EV-303 |
| 47 | 2025-11-25 | Durvalumab (Imfinzi) | AstraZeneca | Resectable gastric or GEJ adenocarcinoma (perioperative) | MATTERHORN |
| 48 | 2025-12-03 | Pirtobrutinib (Jaypirca) | Eli Lilly | Relapsed or refractory CLL/SLL (traditional approval) | BRUIN |
| 49 | 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) | TRANSCEND-FL |
| 50 | 2025-12-12 | Niraparib + Abiraterone acetate (Akeega) | Janssen | BRCA2-mutated metastatic castration-sensitive prostate cancer | MAGNITUDE |
| 51 | 2025-12-15 | Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab | Daiichi Sankyo | First-line unresectable or metastatic HER2-positive breast cancer | DESTINY-Breast09 |
| 52 | 2025-12-17 | Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) | Janssen | Subcutaneous formulation across approved NSCLC indications | PALOMA-3 |
| 53 | 2025-12-17 | Rucaparib (Rubraca) | pharma& GmbH | BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) | TRITON3 |