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-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with Bendamustine/Rituximab) || 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 | | 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-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 | ||
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| 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine- | | 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-mds Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L | ||
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| 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 (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06 | | 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-ultralow-breast-cancer Fam-trastuzumab deruxtecan (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06 | ||
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| 6 || 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 | | 6 || 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 | ||
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| 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1- | | 7 || 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-plexiform-neurofibromas-not-amenable-complete-resection 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-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3 | | 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-lymphoma Brentuximab vedotin (Adcetris)] || Seagen/Pfizer || Relapsed or refractory large B-cell lymphoma || ECHELON-3 | ||
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| 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor || MOTION | | 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Symptomatic tenosynovial giant cell tumor || MOTION | ||
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| 10 || 2025-03-04 || [https://www.fda.gov/drugs/ | | 10 || 2025-03-04 || [https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tevimbra Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306 | ||
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| 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma || ROSEWOOD | ||
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| 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-combination-cisplatin-and-gemcitabine-unresectable-or-metastatic-urothelial Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 | ||
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| 13 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 13 || 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+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 | ||
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| 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive, platinum-resistant ovarian cancer || MIRASOL | ||
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| 15 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 15 || 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 || pNET and epNET indications || CABINET | ||
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| 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 16 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore | ||
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| 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA | ||
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| 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 18 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW | ||
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| 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 | | 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 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 20 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Ipilimumab (Yervoy)] || BMS || First-line unresectable/metastatic HCC || CheckMate-9DW | ||
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| 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 21 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302 | ||
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| 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 22 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low-grade-serous-ovarian-cancer Avutometinib] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low-grade-serous-ovarian-cancer Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201 | ||
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| 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda- | | 23 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selpercatinib-pediatric-patients-two-years-and-older-ret-altered Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer / RET-fusion thyroid cancer / RET-fusion solid tumors || LIBRETTO-121 | ||
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| 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 24 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous metastatic NSCLC || LUMINOSITY | ||
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| 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 25 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-013 | ||
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| 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 26 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma-anal-canal Retifanlimab-dlwr (Zynyz)] || Incyte || Metastatic squamous cell carcinoma of anal canal || POD1UM-303 | ||
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| 27 || 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 | | 27 || 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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| 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 28 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE | ||
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| 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 29 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer Taletrectinib (Ibtrozi)] || Nuvation Bio || Locally advanced or metastatic ROS1+ NSCLC || TRUST-I | ||
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| 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 30 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-for-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689 | ||
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| 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 31 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-for-recurrent-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION | ||
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| 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 32 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory Follicular Lymphoma || inMIND | ||
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| 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 33 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01 | ||
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| 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 34 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E | ||
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| 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 35 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20-insertion-mutations Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 | ||
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| 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 36 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1 | ||
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| 37 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 37 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201 | ||
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| 38 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 38 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1 | ||
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| 39 || 2025-08-25 || [https://www.fda.gov/ | | 39 || 2025-08-25 || [https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219745Orig1s000ltr.pdf Leuprolide mesylate (Camcevi ETM)] || Tolmar || Advanced prostate cancer (3-month injection) || FP-001 LMIS | ||
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| 40 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ | | 40 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC || Bridge | ||
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| 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 with symptomatic plexiform neurofibromas || SPRINT | | 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-who-have-symptomatic-inoperable-plexiform-neurofibromas Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1 with symptomatic plexiform neurofibromas || SPRINT | ||
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| 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 | | 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 || 2025-09-25 || [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 ER+/HER2- breast cancer || EMBER-3 | | 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 ER+/HER2- breast cancer || EMBER-3 | ||
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| 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 (with atezolizumab) || IMforte | | 44 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive-stage-small-cell-lung-cancer Lurbinectedin (Zepzelca)] || Jazz || ES-SCLC maintenance (with atezolizumab) || IMforte | ||
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| 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 | | 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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| 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 | | 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 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia | | 49 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with susceptible NPM1 mutation || KOMET-001 | ||
|- | |- | ||
| 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 (Traditional Approval) || DeLLphi-301 | | 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 (Traditional Approval) || DeLLphi-301 | ||
| Line 105: | Line 105: | ||
| 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 | | 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 | ||
|- | |- | ||
| 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 || R/R CLL or SLL (Traditional Approval) || BRUIN | | 52 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic-lymphoma Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN | ||
|- | |- | ||
| 53 || 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 | | 53 || 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 01:27, 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 -ultralow metastatic breast cancer | DESTINY-Breast06 |
| 6 | 2025-02-10 | Amezalpat (TPST-1120) | Tempest | First-line unresectable or metastatic HCC | Phase 1b/2 Study |
| 7 | 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks | NF1-associated plexiform neurofibromas | ReNeu |
| 8 | 2025-02-11 | Brentuximab vedotin (Adcetris) | Seagen/Pfizer | Relapsed or refractory large B-cell lymphoma | ECHELON-3 |
| 9 | 2025-02-14 | Vimseltinib (Romvimza) | Deciphera | Symptomatic tenosynovial giant cell tumor | MOTION |
| 10 | 2025-03-04 | Tislelizumab-jsgr (Tevimbra) | BeiGene | First-line esophageal squamous cell carcinoma | RATIONALE-306 |
| 11 | 2025-03-05 | Zanubrutinib (Brukinsa) | BeiGene | Relapsed or refractory follicular lymphoma | ROSEWOOD |
| 12 | 2025-03-12 | Nivolumab (Opdivo) | BMS | First-line metastatic urothelial carcinoma | CheckMate-901 |
| 13 | 2025-03-19 | Pembrolizumab (Keytruda) | Merck | HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma | KEYNOTE-811 |
| 14 | 2025-03-22 | Mirvetuximab soravtansine-gynx (Elahere) | ImmunoGen | FRα-positive, platinum-resistant ovarian cancer | MIRASOL |
| 15 | 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | pNET and epNET indications | CABINET |
| 16 | 2025-03-28 | Lutetium Lu 177 (Pluvicto) | Novartis | PSMA+ mCRPC (Pre-taxane) | PSMAfore |
| 17 | 2025-03-28 | Durvalumab (Imfinzi) | AstraZeneca | Neoadjuvant/adjuvant muscle invasive bladder cancer | NIAGARA |
| 18 | 2025-04-08 | Nivolumab (Opdivo) Ipilimumab (Yervoy) |
BMS | MSI-H or 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) Ipilimumab (Yervoy) |
BMS | First-line unresectable/metastatic HCC | CheckMate-9DW |
| 21 | 2025-04-23 | Penpulimab-kcqx | Akeso | First-line non-keratinizing nasopharyngeal carcinoma | AK105-302 |
| 22 | 2025-05-08 | Avutometinib Defactinib (Fakzynja) |
Verastem | KRAS-mutated recurrent LGSOC | RAMP 201 |
| 23 | 2025-05-08 | Selpercatinib (Retevmo) | Eli Lilly | Pediatric RET-altered medullary thyroid cancer / RET-fusion thyroid cancer / RET-fusion solid tumors | LIBRETTO-121 |
| 24 | 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-Met high non-squamous metastatic NSCLC | LUMINOSITY |
| 25 | 2025-05-14 | Belzutifan (Welireg) | Merck | Pheochromocytoma or paraganglioma | LITESPARK-013 |
| 26 | 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Metastatic squamous cell carcinoma of anal canal | POD1UM-303 |
| 27 | 2025-05-30 | Lisocabtagene maraleucel (Breyanzi) | BMS | Relapsed or refractory Mantle Cell Lymphoma | TRANSCEND MCL |
| 28 | 2025-06-03 | Darolutamide (Nubeqa) | Bayer | Metastatic castration-sensitive prostate cancer | ARANOTE |
| 29 | 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1+ NSCLC | TRUST-I |
| 30 | 2025-06-12 | Pembrolizumab (Keytruda) | Merck | Resectable locally advanced HNSCC | KEYNOTE-689 |
| 31 | 2025-06-12 | Mitomycin intravesical (Zusduri) | UroGen | Recurrent LG-IR-NMIBC | ENVISION |
| 32 | 2025-06-18 | Tafasitamab-cxix (Monjuvi) | Incyte | Relapsed or refractory Follicular Lymphoma | inMIND |
| 33 | 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated metastatic NSCLC | TROPION-LUNG01 |
| 34 | 2025-06-27 | Durvalumab (Imfinzi) | AstraZeneca | dMMR advanced or recurrent endometrial cancer | DUO-E |
| 35 | 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal | EGFR Exon 20 insertion mutant NSCLC | WU-KONG6 |
| 36 | 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed or refractory Multiple Myeloma | LINKER-MM1 |
| 37 | 2025-08-06 | Dordaviprone (Modeyso) | Jazz | H3 K27M-mutated progressive midline glioma | ONC201 |
| 38 | 2025-08-08 | Zongertinib (Hernexeos) | Boehringer | Non-squamous NSCLC with HER2 TKD mutations | Beamion LUNG-1 |
| 39 | 2025-08-25 | Leuprolide mesylate (Camcevi ETM) | Tolmar | Advanced prostate cancer (3-month injection) | FP-001 LMIS |
| 40 | 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC | Bridge |
| 41 | 2025-09-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric NF1 with symptomatic plexiform neurofibromas | 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 ER+/HER2- breast cancer | EMBER-3 |
| 44 | 2025-10-02 | Lurbinectedin (Zepzelca) | Jazz | ES-SCLC maintenance (with atezolizumab) | 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 (Traditional Approval) | DeLLphi-301 |
| 51 | 2025-11-25 | Durvalumab (Imfinzi) | AstraZeneca | Resectable gastric or GEJ adenocarcinoma | MATTERHORN |
| 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 |