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FDA Oncology Approvals 2025: Difference between revisions

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! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
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| 1 || 2025-01-16 || [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
| 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
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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-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO
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|| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01
| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-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-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Conditioning for alloHSCT in AML or MDS || MC-FludT.14/L
| 4 || 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 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 HER2-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 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || HER2-low or -ultralow metastatic breast cancer || DESTINY-Breast06
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| 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu
| 6 || 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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| 7 || 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
| 7 || 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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| 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor (TGCT) || MOTION
| 8 || 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
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| 9 || 2025-03-04 || [https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306
| 9 || 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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| 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
| 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET
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| 11 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A
| 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA+ mCRPC (Pre-taxane) || PSMAfore
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| 12 || 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 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA
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| 13 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A
| 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CHECKMATE-8HW
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| 14 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A
| 14 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || Regular approval conversion for MSI-H/dMMR CRC || CHECKMATE-8HW
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| 15 || 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
| 15 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate 9DW
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| 16 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET
| 16 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || First-line non-keratinizing NPC (with chemotherapy) || Study AK105-304
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| 17 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Lutetium Lu 177 (Pluvicto)] || Novartis || PSMA-positive metastatic mCRPC (Earlier use) || PSMAfore
| 17 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx] || Akeso || Monotherapy for previously treated metastatic NPC || Study AK105-202
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| 18 || 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
| 18 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Avutometinib] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201
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| 19 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || MSI-H or dMMR metastatic colorectal cancer || CheckMate-8HW
| 19 || 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 thyroid and solid tumors || LIBRETTO-121
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| 20 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Bevacizumab-nwgdc (Jobevne)] || Biocon Biologics || Biosimilar for various cancer indications || N/A
| 20 || 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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| 21 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE
| 21 || 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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| 22 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Ipilimumab (Yervoy)] || BMS || First-line unresectable or metastatic HCC || CheckMate-9DW
| 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || First-line metastatic anal canal carcinoma || POD1UM-303
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| 23 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Penpulimab-kcqx (Anike)] || Akeso || First-line non-keratinizing nasopharyngeal carcinoma || AK105-302
| 23 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Monotherapy for previously treated metastatic SCAC || POD1UM-303
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| 24 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2
| 24 || 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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| 25 || 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib] <br /> [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Defactinib (Fakzynja)] || Verastem || KRAS-mutated recurrent LGSOC || RAMP 201
| 25 || 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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| 26 || 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
| 26 || 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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| 27 || 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 metastatic non-squamous NSCLC || LUMINOSITY
| 27 || 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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| 28 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013
| 28 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin intravesical (Zusduri)] || UroGen || Recurrent LG-IR-NMIBC || ENVISION
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| 29 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303
| 29 || 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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| 30 || 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
| 30 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated metastatic NSCLC || TROPION-LUNG01
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| 31 || 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
| 31 || 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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| 32 || 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-positive NSCLC || TRUST-I
| 32 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6
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| 33 || 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
| 33 || 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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| 34 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION
| 34 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive midline glioma || ONC201
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| 35 || 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 (FL) || inMIND
| 35 || 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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| 36 || 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
| 36 || 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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| 37 || 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
| 37 || 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 || SunRISe-1
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| 38 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6
| 38 || 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 PN (1 year+) || SPRINT
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| 39 || 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
| 39 || 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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| 40 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201
| 40 || 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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| 41 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Zongertinib (Hernexeos)] || Boehringer || Non-squamous NSCLC with HER2 TKD mutations || Beamion LUNG-1
| 41 || 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
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| 42 || 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 formulation) || FP-001 LMIS
| 42 || 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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| 43 || 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 || N/A
| 43 || 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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| 44 || 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
| 44 || 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
|-
|-
| 45 || 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
| 45 || 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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| 46 || 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 || ER+, HER2-, ESR1-mutated advanced breast cancer || EMBER-3
| 46 || 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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| 47 || 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
| 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A
|-
|-
| 48 || 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
| 48 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory Follicular Lymphoma || EPCORE NHL-1
|-
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| 49 || 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
| 49 || 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-304
|-
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| 50 || 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
| 50 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Sevabertinib (Hyrnuo)] || Bayer || HER2 TKD-mutant non-squamous NSCLC || N/A
|-
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| 51 || 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
| 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 || 2025-12-03 || [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 Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL or SLL (Traditional Approval) || BRUIN-CLL-321
|-
|-
| 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 02:48, 1 January 2026

FDA Oncology Approvals & Major Label Updates 2025
# Approval Date Medication (Brand Name) Company Indication Clinical Trial Name
1 2025-01-16 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 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-nxki (Enhertu) Daiichi Sankyo HER2-low or -ultralow metastatic breast cancer DESTINY-Breast06
6 2025-02-11 Mirdametinib (Gomekli) SpringWorks NF1-associated plexiform neurofibromas ReNeu
7 2025-02-11 Brentuximab vedotin (Adcetris) Pfizer Relapsed or refractory large B-cell lymphoma ECHELON-3
8 2025-02-14 Vimseltinib (Romvimza) Deciphera Symptomatic tenosynovial giant cell tumor MOTION
9 2025-03-19 Pembrolizumab (Keytruda) Merck HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma KEYNOTE-811
10 2025-03-26 Cabozantinib (Cabometyx) Exelixis pNET and epNET indications CABINET
11 2025-03-28 Lutetium Lu 177 (Pluvicto) Novartis PSMA+ mCRPC (Pre-taxane) PSMAfore
12 2025-03-28 Durvalumab (Imfinzi) AstraZeneca Neoadjuvant/adjuvant muscle invasive bladder cancer NIAGARA
13 2025-04-08 Nivolumab (Opdivo)
Ipilimumab (Yervoy)		 BMS MSI-H or dMMR metastatic colorectal cancer CHECKMATE-8HW
14 2025-04-08 Nivolumab (Opdivo) BMS Regular approval conversion for MSI-H/dMMR CRC CHECKMATE-8HW
15 2025-04-11 Nivolumab (Opdivo)
Ipilimumab (Yervoy)		 BMS First-line unresectable or metastatic HCC CheckMate 9DW
16 2025-04-23 Penpulimab-kcqx Akeso First-line non-keratinizing NPC (with chemotherapy) Study AK105-304
17 2025-04-23 Penpulimab-kcqx Akeso Monotherapy for previously treated metastatic NPC Study AK105-202
18 2025-05-08 Avutometinib
Defactinib (Fakzynja)		 Verastem KRAS-mutated recurrent LGSOC RAMP 201
19 2025-05-08 Selpercatinib (Retevmo) Eli Lilly Pediatric RET-altered thyroid and solid tumors LIBRETTO-121
20 2025-05-14 Telisotuzumab vedotin-tllv (Emrelis) AbbVie c-Met high non-squamous metastatic NSCLC LUMINOSITY
21 2025-05-14 Belzutifan (Welireg) Merck Pheochromocytoma or paraganglioma LITESPARK-013
22 2025-05-15 Retifanlimab-dlwr (Zynyz) Incyte First-line metastatic anal canal carcinoma POD1UM-303
23 2025-05-15 Retifanlimab-dlwr (Zynyz) Incyte Monotherapy for previously treated metastatic SCAC POD1UM-303
24 2025-05-30 Lisocabtagene maraleucel (Breyanzi) BMS Relapsed or refractory Mantle Cell Lymphoma TRANSCEND MCL
25 2025-06-03 Darolutamide (Nubeqa) Bayer Metastatic castration-sensitive prostate cancer ARANOTE
26 2025-06-11 Taletrectinib (Ibtrozi) Nuvation Bio Locally advanced or metastatic ROS1+ NSCLC TRUST-I
27 2025-06-12 Pembrolizumab (Keytruda) Merck Resectable locally advanced HNSCC KEYNOTE-689
28 2025-06-12 Mitomycin intravesical (Zusduri) UroGen Recurrent LG-IR-NMIBC ENVISION
29 2025-06-18 Tafasitamab-cxix (Monjuvi) Incyte Relapsed or refractory Follicular Lymphoma inMIND
30 2025-06-23 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo EGFR-mutated metastatic NSCLC TROPION-LUNG01
31 2025-06-27 Durvalumab (Imfinzi) AstraZeneca dMMR advanced or recurrent endometrial cancer DUO-E
32 2025-07-02 Sunvozertinib (Zegfrovy) Dizal EGFR Exon 20 insertion mutant NSCLC WU-KONG6
33 2025-07-02 Linvoseltamab-gcpt (Lynozyfic) Regeneron Relapsed or refractory Multiple Myeloma LINKER-MM1
34 2025-08-06 Dordaviprone (Modeyso) Jazz H3 K27M-mutated progressive midline glioma ONC201
35 2025-08-08 Zongertinib (Hernexeos) Boehringer HER2 TKD-mutant non-squamous NSCLC Beamion LUNG-1
36 2025-08-25 Leuprolide mesylate (Camcevi) Tolmar Advanced prostate cancer (3-month injection) FP-001 LMIS
37 2025-09-09 Gemcitabine intravesical system (Inlexzo) Janssen BCG-unresponsive NMIBC SunRISe-1
38 2025-09-10 Selumetinib (Koselugo) AstraZeneca Pediatric NF1 with symptomatic PN (1 year+) SPRINT
39 2025-09-19 Pembrolizumab subcutaneous (Keytruda Qlex) Merck Subcutaneous solid tumor indications MK-3475-A86
40 2025-09-25 Imlunestrant (Inluriyo) Eli Lilly ESR1-mutated ER+/HER2- breast cancer EMBER-3
41 2025-10-02 Lurbinectedin (Zepzelca) Jazz ES-SCLC maintenance (with atezolizumab) IMforte
42 2025-10-08 Cemiplimab-rwlc (Libtayo) Regeneron Adjuvant cutaneous squamous cell carcinoma C-POST
43 2025-10-23 Belantamab mafodotin-blmf (Blenrep) GSK Relapsed or refractory Multiple Myeloma DREAMM-7
44 2025-10-24 Revumenib (Revuforj) Syndax NPM1-mutant relapsed or refractory AML AUGMENT-101
45 2025-11-06 Daratumumab subcutaneous (Darzalex Faspro) Janssen High-risk smoldering multiple myeloma AQUILA
46 2025-11-13 Ziftomenib (Komzifti) Kura Oncology R/R AML with susceptible NPM1 mutation KOMET-001
47 2025-11-13 Pertuzumab-dpzb (Poherdy) Henlius Interchangeable biosimilar to Perjeta N/A
48 2025-11-18 Epcoritamab-bysp (Epkinly) Genmab Relapsed or refractory Follicular Lymphoma EPCORE NHL-1
49 2025-11-19 Tarlatamab-dlle (Imdelltra) Amgen Extensive stage SCLC (Traditional Approval) DeLLphi-304
50 2025-11-19 Sevabertinib (Hyrnuo) Bayer HER2 TKD-mutant non-squamous NSCLC N/A
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-CLL-321
53 2025-12-17 Amivantamab subcutaneous (Rybrevant Faspro) Janssen Subcutaneous delivery for all indications PALOMA-3
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