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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 || Acalabrutinib (Calquence) || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) ||  
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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 || Sotorasib (Lumakras) <br /> Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer ||  
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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 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer ||  
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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 || Treosulfan (Grafapex) || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS ||  
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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 || Fam-trastuzumab deruxtecan-nxki (Enhertu) || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer ||  
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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 || Mirdametinib (Gomekli) || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) ||  
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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 || 2025-02-12 || Brentuximab vedotin (Adcetris) || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) ||  
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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 || Vimseltinib (Romvimza) || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) ||  
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| 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811
| 9 || 2025-03-19 || Pembrolizumab (Keytruda) || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) ||  
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| 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || pNET and epNET indications || CABINET
| 10 || 2025-03-26 || Cabozantinib (Cabometyx) || Exelixis || Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) ||  
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| 11 || 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
| 11 || 2025-03-28 || Durvalumab (Imfinzi) || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) ||  
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| 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
| 12 || 2025-03-28 || Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) ||  
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| 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
| 13 || 2025-04-08 || Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer ||  
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| 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
| 14 || 2025-04-11 || Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy) || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) ||  
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| 15 || 2025-04-11 || [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
| 15 || 2025-04-23 || Penpulimab-kcqx || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) ||  
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| 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
| 16 || 2025-05-08 || Avutometinib + Defactinib || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) ||  
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| 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
| 17 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || AbbVie || NSCLC with high c-Met overexpression (accelerated) ||  
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| 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
| 18 || 2025-05-14 || Belzutifan (Welireg) || Merck || Pheochromocytoma or paraganglioma ||  
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| 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
| 19 || 2025-05-15 || Retifanlimab-dlwr (Zynyz) || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) ||  
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| 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
| 20 || 2025-06-03 || Darolutamide (Nubeqa) || Bayer || Metastatic castration-sensitive prostate cancer (expanded) ||  
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| 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
| 21 || 2025-06-11 || Taletrectinib (Ibtrozi) || Nuvation Bio || ROS1-positive NSCLC ||  
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| 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
| 22 || 2025-06-12 || Pembrolizumab (Keytruda) || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) ||  
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| 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
| 23 || 2025-06-12 || Mitomycin intravesical solution (Zusduri) || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC ||  
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| 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
| 24 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) ||  
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| 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
| 25 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) ||  
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| 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
| 26 || 2025-07-02 || Sunvozertinib (Zegfrovy) || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) ||  
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| 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
| 27 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) ||  
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| 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
| 28 || 2025-08-06 || Dordaviprone (Modeyso) || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) ||  
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| 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
| 29 || 2025-08-08 || Zongertinib (Hernexeos) || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) ||  
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| 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
| 30 || 2025-09-09 || Gemcitabine intravesical system (Inlexzo) || Janssen || BCG-unresponsive NMIBC with CIS ||  
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| 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
| 31 || 2025-09-10 || Selumetinib (Koselugo) || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) ||  
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| 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
| 32 || 2025-09-19 || Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) || Merck || Subcutaneous formulation across approved solid tumor indications ||  
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| 33 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory Multiple Myeloma || LINKER-MM1
| 33 || 2025-09-25 || Imlunestrant (Inluriyo) || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer ||  
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| 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
| 34 || 2025-10-02 || Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer ||  
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| 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
| 35 || 2025-10-08 || Cemiplimab-rwlc (Libtayo) || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) ||  
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| 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
| 36 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) ||  
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| 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
| 37 || 2025-10-24 || Revumenib (Revuforj) || Syndax || NPM1-mutated relapsed or refractory AML (adult & pediatric ≥1 year) ||  
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| 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
| 38 || 2025-11-06 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || High-risk smoldering multiple myeloma ||  
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| 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
| 39 || 2025-11-13 || Ziftomenib (Komzifti) || Kura Oncology || NPM1-mutated relapsed or refractory AML ||  
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| 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
| 40 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta ||  
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| 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
| 41 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) ||  
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| 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
| 42 || 2025-11-19 || Selumetinib (Koselugo) || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas ||  
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| 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
| 43 || 2025-11-19 || Daratumumab and hyaluronidase-fihj (Darzalex Faspro) || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) ||  
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| 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
| 44 || 2025-11-19 || Sevabertinib (Hyrnuo) || Bayer || HER2-mutated non-squamous NSCLC (accelerated) ||  
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| 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
| 45 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Amgen || Extensive-stage small cell lung cancer (traditional approval) ||  
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| 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
| 46 || 2025-11-21 || Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) ||  
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| 47 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pertuzumab-dpzb (Poherdy)] || Henlius || Interchangeable biosimilar to Perjeta || N/A
| 47 || 2025-11-25 || Durvalumab (Imfinzi) || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) ||  
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| 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
| 48 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) ||  
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| 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
| 49 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) ||  
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| 50 || 2025-11-19 || [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
| 50 || 2025-12-12 || Niraparib + Abiraterone acetate (Akeega) || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer ||  
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| 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 || 2025-12-15 || Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer ||  
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| 52 || 2025-12-03 || [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
| 52 || 2025-12-17 || Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) || Janssen || Subcutaneous formulation across approved NSCLC indications ||  
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| 53 || 2025-12-17 || [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 || Rucaparib (Rubraca) || pharma& GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) ||  
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Revision as of 10:44, 1 January 2026

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