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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 || Acalabrutinib (Calquence) || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) ||  
| 1 || 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 and rituximab) || ECHO
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| 2 || 2025-01-16 || Sotorasib (Lumakras) <br /> Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer ||  
| 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] <br /> Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300
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| 3 || 2025-01-17 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer ||  
| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01
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| 4 || 2025-01-21 || Treosulfan (Grafapex) || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS ||  
| 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L
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| 5 || 2025-01-27 || Fam-trastuzumab deruxtecan-nxki (Enhertu) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer ||  
| 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06
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| 6 || 2025-02-11 || Mirdametinib (Gomekli) || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) ||  
| 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) || ReNeu
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| 7 || 2025-02-12 || Brentuximab vedotin (Adcetris) || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) ||  
| 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3
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| 8 || 2025-02-14 || Vimseltinib (Romvimza) || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) ||  
| 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION
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| 9 || 2025-03-19 || Pembrolizumab (Keytruda) || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) ||  
| 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811
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| 10 || 2025-03-26 || Cabozantinib (Cabometyx) || Exelixis || Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) ||  
| 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) || CABINET
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| 11 || 2025-03-28 || Durvalumab (Imfinzi) || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) ||  
| 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA
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| 12 || 2025-03-28 || Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) ||  
| 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore
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| 13 || 2025-04-08 || Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer ||
| 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved
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| 14 || 2025-04-11 || Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) ||
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| 15 || 2025-04-23 || Penpulimab-kcqx || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) ||
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| 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) ||
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| 17 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || NSCLC with high c-Met overexpression (accelerated) ||
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| 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma ||
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| 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) ||
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| 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) ||
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| 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC ||
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| 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) ||
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| 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC ||
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| 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) ||
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| 25 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) ||
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| 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) ||
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| 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) ||
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| 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) ||
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| 29 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) ||
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| 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS ||
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| 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) ||
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| 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications ||
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| 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer ||
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| 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer ||
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| 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) ||
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| 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) ||
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| 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult & pediatric ≥1 year) ||
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| 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma ||
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| 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML ||
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| 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta ||
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| 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) ||
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| 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas ||
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| 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) ||
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| 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) ||
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| 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) ||
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| 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) ||
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| 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) ||
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| 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) ||
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| 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) ||
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| 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer ||
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| 51 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer ||
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| 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications ||
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| 53 || 2025-12-17 || Rucaparib (Rubraca) || pharma& GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) ||
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Revision as of 10:48, 1 January 2026

FDA Oncology Approvals & Major Label Updates 2025
# 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 [https://www.fda.gov/drugs/resources-information-approved
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