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FDA Oncology Approvals 2025: Difference between revisions

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|+ FDA Approved Oncology Drugs & Major Label Updates 2025
|+ FDA Oncology Approvals & Major Label Updates 2025
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
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| 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L
| 5 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L
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| 6 || 2025-01-27 || [https://www.aptitudehealth.com/oncology-news/most-fda-and-ema-oncology-drug-approvals-in-q1-2025-were-new-indications-for-biologics-and-biosimilars/ Trastuzumab deruxtecan (Enhertu)] || AstraZeneca || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06
| 6 || 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 Trastuzumab deruxtecan (Enhertu)] || AstraZeneca || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06
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| 7 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line unresectable or metastatic HCC || Phase 1b/2 Study
| 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu
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| 8 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu
| 8 || 2025-02-11 || [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 || ECHELON-3
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| 9 || 2025-02-11 || [https://www.aptitudehealth.com/oncology-news Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory Large B-Cell Lymphoma || Phase 3 trial
| 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION
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| 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION
| 10 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227
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| 11 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227
| 11 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306
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| 12 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line PD-L1+ esophageal squamous cell carcinoma || RATIONALE-306
| 12 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD
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| 13 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD
| 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901
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| 14 || 2025-03-07 || [https://www.aptitudehealth.com/oncology-news Dabrafenib mesylate (Tafinlar)] || Novartis || Expanded use in pediatric BRAF-mutant melanoma || Pediatric Study
| 14 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811
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| 15 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901
| 15 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL
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| 16 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Binimetinib (Mektovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial
| 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET
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| 17 || 2025-03-12 || [https://www.aptitudehealth.com/oncology-news Encorafenib (Braftovi)] || Pfizer || Combination use in metastatic NSCLC || Phase 3 trial
| 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || Pre-taxane metastatic mCRPC || PSMAfore
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| 18 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811
| 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW
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| 19 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL
| 19 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4
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| 20 || 2025-03-25 || [https://www.aptitudehealth.com/oncology-news Denosumab (Osenvelt)] || Fresenius Kabi || Biosimilar for prostate and breast cancer bone loss || Biosimilar Study
| 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW
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| 21 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET
| 21 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW
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| 22 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || Pre-taxane metastatic prostate cancer || PSMAfore
| 22 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma || AK105-302
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| 23 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW
| 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201
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| 24 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW
| 24 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201
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| 25 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for CRC, NSCLC, and other solid tumors || Biosimilar Study
| 25 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121
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| 26 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion-positive solid tumors || NAVIGATE
| 26 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY
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| 27 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R Multiple Myeloma after one prior line || CARTITUDE-4
| 27 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013
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| 28 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW
| 28 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL
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| 29 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW
| 29 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE
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| 30 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso Biopharma || Metastatic non-keratinizing nasopharyngeal carcinoma || AK105-302
| 30 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I
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| 31 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded use in HR+/HER2- breast cancer || PALOMA-2
| 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689
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| 32 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201
| 32 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical solution (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION
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| 33 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201
| 33 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND
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| 34 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121
| 34 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01
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| 35 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY
| 35 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E
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| 36 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Metastatic pheochromocytoma or paraganglioma || LITESPARK-013
| 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6
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| 37 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303
| 37 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1
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| 38 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL
| 38 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated diffuse midline glioma || ONC201
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| 39 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I
| 39 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1
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| 40 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Neoadjuvant/adjuvant locally advanced head and neck cancer || Phase 3 trial
| 40 || 2025-08-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Leuprolide mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS
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| 41 || 2025-06-12 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mitomycin (Zusduri)] || UroGen Pharma || Recurrent low-grade non-muscle invasive bladder cancer || Phase 3 Study
| 41 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1-symptomatic Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT
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| 42 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND
| 42 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab subcutaneous (Keytruda Qlex)] || Merck || Subcutaneous solid tumor indications || MK-3475-A86
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| 43 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01
| 43 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced breast cancer || EMBER-3
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| 44 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E
| 44 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance || IMforte
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| 45 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant metastatic NSCLC || WU-KONG6
| 45 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma || C-POST
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| 46 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1
| 46 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GSK || Relapsed or refractory Multiple Myeloma || DREAMM-7
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| 47 || 2025-08-06 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201
| 47 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101
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| 48 || 2025-08-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2 TKD-mutant non-squamous metastatic NSCLC || Beamion LUNG-1
| 48 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab subcutaneous (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA
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| 49 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous adult/pediatric solid tumor indications || MK-3475
| 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001
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| 50 || 2025-09-25 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced or metastatic breast cancer || EMBER-3
| 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive stage SCLC (Full Approval) || DeLLphi-301
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| 51 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101
| 51 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN
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| 52 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001
| 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (Full Approval) || BRUIN
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| 53 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN
| 53 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib (Akeega)] || Janssen || BRCA2-mutated mCSPC || MAGNITUDE
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| 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] || Janssen || Subcutaneous NSCLC delivery (All indications) || PALOMA-3
| 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3
|}
|}

Revision as of 00:28, 1 January 2026

FDA Oncology Approvals & Major Label Updates 2025
# Approval Date Medication (Brand Name) Company Indication Clinical Trial Name
1 2025-01-16 Sotorasib (Lumakras) Amgen KRAS G12C–mutated metastatic colorectal cancer CodeBreaK 300
2 2025-01-16 Panitumumab (Vectibix) Amgen KRAS G12C–mutated metastatic colorectal cancer CodeBreaK 300
3 2025-01-16 Acalabrutinib (Calquence) AstraZeneca Previously untreated mantle cell lymphoma ECHO
4 2025-01-17 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo HR-positive, HER2-negative metastatic breast cancer TROPION-Breast01
5 2025-01-21 Treosulfan (Grafapex) medac GmbH Conditioning for allogeneic HSCT in AML or MDS MC-FludT.14/L
6 2025-01-27 Trastuzumab deruxtecan (Enhertu) AstraZeneca HER2-low or HER2-ultralow metastatic breast cancer DESTINY-Breast06
7 2025-02-11 Mirdametinib (Gomekli) SpringWorks NF1-associated plexiform neurofibromas ReNeu
8 2025-02-11 Brentuximab vedotin (Adcetris) Pfizer Relapsed or refractory Large B-Cell Lymphoma ECHELON-3
9 2025-02-14 Vimseltinib (Romvimza) Deciphera Tenosynovial giant cell tumor (TGCT) MOTION
10 2025-02-14 Pembrolizumab (Keytruda) Merck First-line metastatic pleural mesothelioma IND.227
11 2025-03-04 Tislelizumab-jsgr (Tevimbra) BeiGene First-line esophageal squamous cell carcinoma RATIONALE-306
12 2025-03-05 Zanubrutinib (Brukinsa) BeiGene Relapsed or refractory follicular lymphoma (FL) ROSEWOOD
13 2025-03-12 Nivolumab (Opdivo) BMS First-line metastatic urothelial carcinoma CheckMate-901
14 2025-03-19 Pembrolizumab (Keytruda) Merck HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma KEYNOTE-811
15 2025-03-22 Mirvetuximab soravtansine-gynx (Elahere) ImmunoGen FRα-positive, platinum-resistant ovarian cancer MIRASOL
16 2025-03-26 Cabozantinib (Cabometyx) Exelixis Pancreatic neuroendocrine tumors (pNETs) CABINET
17 2025-03-28 Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) Novartis Pre-taxane metastatic mCRPC PSMAfore
18 2025-04-08 Nivolumab (Opdivo) BMS MSI-H/dMMR metastatic colorectal cancer CheckMate-8HW
19 2025-04-10 Ciltacabtagene autoleucel (Carvykti) Janssen R/R Multiple Myeloma after one prior line CARTITUDE-4
20 2025-04-11 Nivolumab (Opdivo) BMS First-line unresectable/metastatic HCC CheckMate-9DW
21 2025-04-11 Ipilimumab (Yervoy) BMS First-line unresectable/metastatic HCC CheckMate-9DW
22 2025-04-23 Penpulimab-kcqx Akeso Biopharma Non-keratinizing nasopharyngeal carcinoma AK105-302
23 2025-05-08 Avutometinib Verastem KRAS-mutated recurrent low-grade serous ovarian cancer RAMP 201
24 2025-05-08 Defactinib (Fakzynja) Verastem KRAS-mutated recurrent low-grade serous ovarian cancer RAMP 201
25 2025-05-08 Selpercatinib (Retevmo) Eli Lilly Pediatric RET-altered medullary thyroid cancer LIBRETTO-121
26 2025-05-14 Telisotuzumab vedotin-tllv (Emrelis) AbbVie c-Met high non-squamous metastatic NSCLC LUMINOSITY
27 2025-05-14 Belzutifan (Welireg) Merck Pheochromocytoma or paraganglioma LITESPARK-013
28 2025-05-30 Lisocabtagene maraleucel (Breyanzi) BMS Relapsed or refractory Mantle Cell Lymphoma TRANSCEND MCL
29 2025-06-03 Darolutamide (Nubeqa) Bayer Metastatic castration-sensitive prostate cancer ARANOTE
30 2025-06-11 Taletrectinib (Ibtrozi) Nuvation Bio Locally advanced or metastatic ROS1+ NSCLC TRUST-I
31 2025-06-12 Pembrolizumab (Keytruda) Merck Resectable locally advanced HNSCC KEYNOTE-689
32 2025-06-12 Mitomycin intravesical solution (Zusduri) UroGen Recurrent low-grade intermediate-risk NMIBC ENVISION
33 2025-06-18 Tafasitamab-cxix (Monjuvi) Incyte Relapsed or refractory Follicular Lymphoma inMIND
34 2025-06-23 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo EGFR-mutated advanced/metastatic NSCLC TROPION-LUNG01
35 2025-06-27 Durvalumab (Imfinzi) AstraZeneca dMMR advanced or recurrent endometrial cancer DUO-E
36 2025-07-02 Sunvozertinib (Zegfrovy) Dizal Pharma EGFR Exon 20 insertion mutant NSCLC WU-KONG6
37 2025-07-02 Linvoseltamab-gcpt (Lynozyfic) Regeneron Relapsed or refractory Multiple Myeloma LINKER-MM1
38 2025-08-06 Dordaviprone (Modeyso) Jazz H3 K27M-mutated diffuse midline glioma ONC201
39 2025-08-08 Zongertinib (Hernexeos) Boehringer HER2 TKD-mutant non-squamous NSCLC Beamion LUNG-1
40 2025-08-25 Leuprolide mesylate (Camcevi) Tolmar Advanced prostate cancer (3-month injection) FP-001 LMIS
41 2025-09-10 Selumetinib (Koselugo) AstraZeneca Pediatric NF1 plexiform neurofibromas (Granules) SPRINT
42 2025-09-19 Pembrolizumab subcutaneous (Keytruda Qlex) Merck Subcutaneous solid tumor indications MK-3475-A86
43 2025-09-25 Imlunestrant (Inluriyo) Eli Lilly ESR1-mutated advanced breast cancer EMBER-3
44 2025-10-02 Lurbinectedin (Zepzelca) Jazz ES-SCLC maintenance IMforte
45 2025-10-08 Cemiplimab-rwlc (Libtayo) Regeneron Adjuvant cutaneous squamous cell carcinoma C-POST
46 2025-10-23 Belantamab mafodotin-blmf (Blenrep) GSK Relapsed or refractory Multiple Myeloma DREAMM-7
47 2025-10-24 Revumenib (Revuforj) Syndax NPM1-mutant relapsed or refractory AML AUGMENT-101
48 2025-11-06 Daratumumab subcutaneous (Darzalex Faspro) Janssen High-risk smoldering multiple myeloma AQUILA
49 2025-11-13 Ziftomenib (Komzifti) Kura Oncology R/R AML with susceptible NPM1 mutation KOMET-001
50 2025-11-19 Tarlatamab-dlle (Imdelltra) Amgen Extensive stage SCLC (Full Approval) DeLLphi-301
51 2025-11-25 Durvalumab (Imfinzi) AstraZeneca Resectable gastric or GEJ adenocarcinoma MATTERHORN
52 2025-12-03 Pirtobrutinib (Jaypirca) Eli Lilly Relapsed or refractory CLL/SLL (Full Approval) BRUIN
53 2025-12-12 Niraparib (Akeega) Janssen BRCA2-mutated mCSPC MAGNITUDE
54 2025-12-17 Amivantamab subcutaneous (Rybrevant Faspro) Janssen Subcutaneous delivery for all indications PALOMA-3
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