FDA Oncology Approvals 2025: Difference between revisions
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| class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |- | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 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)] <br /> Bendamustine <br /> Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |- | 3 || 2025-01-17 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 4 || 2025-01-21 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Treosulfan (Grafapex)] <br /> Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 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 |- | 9 || 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+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 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 |- | 11 || 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 |- | 12 || 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 |- | 13 || 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 |- | 14 || 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 |- | 15 || 2025-03-28 || [https://www.mskcc.org/news/msk-led-research-resulted-in-11-new-fda-approvals-for-cancer-drugs-in-2025 177Lu-PSMA-617 (Pluvicto)] || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Fitusiran (Qfitlia)] || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Atrasentan (Vanrafia)] || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || [https://ascopost.com/issues/december-10-2025/new-fda-approved-oncology-drugs-and-label-updates-between-december-1-2024-and-november-19-2025/ Nivolumab (Opdivo)] <br /> [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 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 (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || [https://ascopost.com/issues/december-10-2025 Nivolumab (Opdivo)] <br /> [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || [https://www.aptitudehealth.com/oncology-news Palonosetron (Posfrea)] || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Penpulimab-kcqx (Anike)] || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Nipocalimab-aahu (Imaavy)] || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] <br /> [https://www.mskcc.org/news Defactinib (Avmapki Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 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 |- | 29 || 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 |- | 30 || 2025-05-14 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 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 |- | 34 || 2025-06-03 || [https://ascopost.com/issues/december-10-2025 Darolutamide (Nubeqa)] || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 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 |- | 36 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Talazoparib (Talzenna)] || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Mitomycin (Zusduri)] || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || [https://ascopost.com/issues/december-10-2025 Tafasitamab-cxix (Monjuvi)] <br /> Lenalidomide <br /> Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || [https://ascopost.com/issues/december-10-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || [https://ascopost.com/issues/december-10-2025 Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 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 |- | 44 || 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 |- | 45 || 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 NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || [https://www.cancernetwork.com/view/spotlighting-the-top-10-fda-oncology-approvals-in-2025 Leuprolide Mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || [https://ascopost.com/issues/december-10-2025 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || [https://www.mskcc.org/news Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || [https://www.mskcc.org/news Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || [https://ascopost.com/issues/december-10-2025 Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 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 |- | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] <br /> Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |} | | class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |- | ||
| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 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)] <br /> Bendamustine <br /> Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |- | 3 || 2025-01-17 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 4 || 2025-01-21 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Treosulfan (Grafapex)] <br /> Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || [https://www.aacr.org/blog/2025/10/02/fda-approvals-in-oncology-july-september-2025/ Amezalpat (TPST-1120)] || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 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 |- | 9 || 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+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 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 |- | 11 || 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 |- | 12 || 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 |- | 13 || 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 |- | 14 || 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 |- | 15 || 2025-03-28 || [https://www.mskcc.org/news/msk-led-research-resulted-in-11-new-fda-approvals-for-cancer-drugs-in-2025 177Lu-PSMA-617 (Pluvicto)] || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Fitusiran (Qfitlia)] || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Atrasentan (Vanrafia)] || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || [https://ascopost.com/issues/december-10-2025/new-fda-approved-oncology-drugs-and-label-updates-between-december-1-2024-and-november-19-2025/ Nivolumab (Opdivo)] <br /> [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || [https://www.aptitudehealth.com/oncology-news Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 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 (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || [https://ascopost.com/issues/december-10-2025 Nivolumab (Opdivo)] <br /> [https://ascopost.com/issues/december-10-2024 Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || [https://www.aptitudehealth.com/oncology-news Palonosetron (Posfrea)] || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Penpulimab-kcqx (Anike)] || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || [https://www.aptitudehealth.com/oncology-news Palbociclib (Ibrance)] || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || [https://www.greyb.com/blog/fda-drug-approvals-2025/ Nipocalimab-aahu (Imaavy)] || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] <br /> [https://www.mskcc.org/news Defactinib (Avmapki Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 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 |- | 29 || 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 |- | 30 || 2025-05-14 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || [https://www.aptitudehealth.com/oncology-news Retifanlimab-dlwr (Zynyz)] || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || [https://ascopost.com/issues/december-10-2025 Belzutifan (Welireg)] || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 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 |- | 34 || 2025-06-03 || [https://ascopost.com/issues/december-10-2025 Darolutamide (Nubeqa)] || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 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 |- | 36 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Pembrolizumab (Keytruda)] || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Talazoparib (Talzenna)] || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || [https://www.aptitudehealth.com/oncology-news Mitomycin (Zusduri)] || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || [https://ascopost.com/issues/december-10-2025 Tafasitamab-cxix (Monjuvi)] <br /> Lenalidomide <br /> Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || [https://ascopost.com/issues/december-10-2025 Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || [https://ascopost.com/issues/december-10-2025 Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Sunvozertinib (Zegfrovy)] || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 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 |- | 44 || 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 |- | 45 || 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 NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || [https://www.cancernetwork.com/view/spotlighting-the-top-10-fda-oncology-approvals-in-2025 Leuprolide Mesylate (Camcevi)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || [https://ascopost.com/issues/december-10-2025 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Keytruda Qlex (Pembrolizumab subcutaneous)] || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || [https://www.mskcc.org/news Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || [https://www.mskcc.org/news Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || [https://ascopost.com/issues/december-10-2025 Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 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 |- | 54 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Amivantamab (Rybrevant Faspro)] <br /> Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |} | |||
Revision as of 00:13, 1 January 2026
| class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! 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)
Bendamustine
Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || 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)
Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-02-10 || Amezalpat (TPST-1120) || Tempest || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 6 || 2025-02-11 || Mirdametinib (Gomekli) || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 7 || 2025-02-14 || Vimseltinib (Romvimza) || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 8 || 2025-02-14 || Pembrolizumab (Keytruda) || Merck || First-line metastatic pleural mesothelioma || IND.227 |- | 9 || 2025-03-04 || Tislelizumab-jsgr (Tevimbra) || BeiGene || First-line PD-L1+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 10 || 2025-03-05 || Zanubrutinib (Brukinsa) || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |- | 11 || 2025-03-12 || Nivolumab (Opdivo) || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 |- | 12 || 2025-03-19 || Pembrolizumab (Keytruda) || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 |- | 13 || 2025-03-22 || Mirvetuximab soravtansine-gynx (Elahere) || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL |- | 14 || 2025-03-26 || Cabozantinib (Cabometyx) || Exelixis || Pancreatic neuroendocrine tumors (pNETs) || CABINET |- | 15 || 2025-03-28 || 177Lu-PSMA-617 (Pluvicto) || Novartis || Metastatic prostate cancer (Earlier use) || PSMAfore |- | 16 || 2025-03-28 || Fitusiran (Qfitlia) || Sanofi || Hemophilia A and B prophylaxis || ATLAS Study |- | 17 || 2025-04-02 || Atrasentan (Vanrafia) || Novartis || Proteinuria reduction in IgA nephropathy || ALIGN |- | 18 || 2025-04-08 || Nivolumab (Opdivo)
Ipilimumab (Yervoy) || BMS || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 19 || 2025-04-09 || Bevacizumab-nwgdc (Jobevne) || Biocon Biologics || Biosimilar for multiple cancers || Biosimilar Study |- | 20 || 2025-04-09 || Larotrectinib (Vitrakvi) || Bayer || NTRK gene fusion solid tumors || NAVIGATE |- | 21 || 2025-04-10 || Ciltacabtagene autoleucel (Carvykti) || Janssen || R/R Multiple Myeloma (Second line) || CARTITUDE-4 |- | 22 || 2025-04-11 || Nivolumab (Opdivo)
Ipilimumab (Yervoy) || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW |- | 23 || 2025-04-16 || Palonosetron (Posfrea) || Avyxa Pharma || Antiemetic for chemotherapy-induced nausea || Supportive Care |- | 24 || 2025-04-23 || Penpulimab-kcqx (Anike) || Akeso Biopharma || Recurrent/metastatic nasopharyngeal carcinoma || AK105-302 |- | 25 || 2025-04-23 || Palbociclib (Ibrance) || Pfizer || Expanded indication for breast cancer || PALOMA-2/3 |- | 26 || 2025-04-29 || Nipocalimab-aahu (Imaavy) || Janssen || Generalized Myasthenia Gravis || VIVACITY-MG3 |- | 27 || 2025-05-08 || Avutometinib
Defactinib (Avmapki Fakzynja) || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 |- | 28 || 2025-05-08 || Selpercatinib (Retevmo) || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121 |- | 29 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY |- | 30 || 2025-05-14 || Belzutifan (Welireg) || Merck || Advanced pheochromocytoma/paraglioma || LITESPARK-013 |- | 31 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte Corp || First-line squamous cell anal carcinoma || POD1UM-303 |- | 32 || 2025-05-26 || Belzutifan (Welireg) || Merck || Advanced Clear Cell Renal Cell Carcinoma || LITESPARK-005 |- | 33 || 2025-05-30 || Lisocabtagene maraleucel (Breyanzi) || BMS || Relapsed or refractory Mantle Cell Lymphoma || TRANSCEND MCL |- | 34 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic hormone-sensitive prostate cancer || ARANOTE |- | 35 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 36 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Head and neck squamous cell carcinoma || Phase 3 trial |- | 37 || 2025-06-12 || Talazoparib (Talzenna) || Pfizer || Metastatic castration-resistant prostate cancer || TALAPRO-2 |- | 38 || 2025-06-12 || Mitomycin (Zusduri) || UroGen Pharma || Bladder cancer hydrogel formulation || Phase 3 Study |- | 39 || 2025-06-18 || Tafasitamab-cxix (Monjuvi)
Lenalidomide
Rituximab || Incyte Corp || Relapsed or refractory Follicular Lymphoma || inMIND |- | 40 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated advanced/metastatic NSCLC || TROPION-LUNG01 |- | 41 || 2025-06-27 || Durvalumab (Imfinzi) || AstraZeneca || dMMR advanced/recurrent endometrial cancer || DUO-E |- | 42 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharma || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |- | 43 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1 |- | 44 || 2025-08-06 || Dordaviprone (Modeyso) || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 45 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2 TKD-mutant non-squamous NSCLC || Beamion LUNG-1 |- | 46 || 2025-08-08 || Leuprolide Mesylate (Camcevi) || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS |- | 47 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1 plexiform neurofibromas (Granules) || SPRINT |- | 48 || 2025-09-19 || Keytruda Qlex (Pembrolizumab subcutaneous) || Merck || Subcutaneous solid cancer indications || MK-3475 |- | 49 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 50 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 51 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 52 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius || Interchangeable biosimilar for breast cancer || Biosimilar Study |- | 53 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma || MATTERHORN |- | 54 || 2025-12-17 || Amivantamab (Rybrevant Faspro)
Hyaluronidase-lpuj || Janssen || Subcutaneous delivery (All indications) || PALOMA-3 |}