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| ! Item Number !! Approval Date !! Approval Type !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name !! FDA Approval Link | | |+ FDA Oncology Approvals & Major Label Updates 2025 |
| | ! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name |
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| | 1 || 12/17/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen Biotech, Inc. || subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection | | | 1 || 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 and rituximab) || ECHO |
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| | 2 || 12/17/2025 || Regular approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer rucaparib (Rubraca)] || pharmaand GmbH || adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer | | | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] <br /> Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |
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| | 3 || 12/15/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive-breast-cancer fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo, Inc. || the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive-breast-cancer | | | 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 || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01 |
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| | 4 || 12/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration-sensitive-prostate-cancer niraparib and abiraterone acetate (Akeega)] || Janssen Biotech, Inc. || adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration-sensitive-prostate-cancer | | | 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 || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L |
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| | 5 || 12/4/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma lisocabtagene maraleucel (Breyanzi)] || Juno Therapeutics, Inc., a Bristol-Myers Squibb Company || adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma | | | 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 || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06 |
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| | 6 || 12/3/2025 || Traditional approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic pirtobrutinib (Jaypirca)] || Eli Lilly and Company || adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic | | | 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 Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) || ReNeu |
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| | 7 || 11/25/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma durvalumab (Imfinzi)] || AstraZeneca || approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma | | | 7 || 2025-02-12 || [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 (with lenalidomide and rituximab) || ECHELON-3 |
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| | 8 || 11/21/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer pembrolizumab (Keytruda)] || Merck || approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer | | | 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION |
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| | 9 || 11/19/2025 || Traditional approval || [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 Inc. || adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer | | | 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-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811 |
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| | 10 || 11/19/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer sevabertinib (Hyrnuo)] || Bayer HealthCare Pharmaceuticals Inc. || adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer | | | 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 || Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) || CABINET |
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| | 11 || 11/19/2025 || Traditional approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen Biotech Inc. || granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain | | | 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA |
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| | 12 || 11/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform selumetinib (KOSELUGO)] || AstraZeneca Pharmaceuticals LP || adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform | | | 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore |
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| | 13 || 11/18/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications epcoritamab-bysp (Epkinly)] || Genmab US, Inc. || approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL); also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications | | | 13 || 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 /> Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW |
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| | 14 || 11/13/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Poherdy (pertuzumab-dpzb)] || Shanghai Henlius Biologics Co. Ltd. || an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta | | | 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW |
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| | 15 || 11/13/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation ziftomenib (Komzifti)] || Kura Oncology, Inc. || adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation | | | 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304 |
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| | 16 || 11/6/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen Biotech, Inc. || adults with high-risk smoldering multiple myeloma (SMM) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma | | | 16 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low Avutometinib + Defactinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201 |
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| | 17 || 10/24/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation revumenib (Revuforj)] || Syndax Pharmaceuticals, Inc. || relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation | | | 17 || 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 || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY |
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| | 18 || 10/23/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma belantamab mafodotin-blmf (Blenrep)] || GlaxoSmithKline || with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma | | | 18 || 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-016 |
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| | 19 || 10/8/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma cemiplimab-rwlc (Libtayo)] || Regeneron Pharmaceuticals Inc. || the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma | | | 19 || 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 Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303 |
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| | 20 || 10/2/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive lurbinectedin (Zepzelca)] || Jazz Pharmaceuticals, Inc. || in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive | | | 20 || 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 (expanded) || ARANOTE |
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| | 21 || 9/25/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast imlunestrant (Inluriyo)] || Eli Lilly and Company || adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast | | | 21 || 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 || ROS1-positive NSCLC || TRUST-II |
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| | 22 || 9/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection | | | 22 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck Pembrolizumab (Keytruda)] || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689 |
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| | 23 || 9/10/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 selumetinib (KOSELUGO)] || AstraZeneca Pharmaceuticals LP || granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 | | | 23 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle Mitomycin intravesical solution (Zusduri)] || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION |
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| | 24 || 9/9/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer gemcitabine intravesical system (Inlexzo)] || Janssen Biotech, Inc. || adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer | | | 24 || 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 (with lenalidomide + rituximab) || inMIND |
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| | 25 || 8/8/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations zongertinib (Hernexeos)] || Boehringer Ingelheim Pharmaceuticals, Inc. || adults with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations | | | 25 || 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 locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05 |
| |- | | |- |
| | 26 || 8/6/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma dordaviprone (Modeyso)] || Jazz Pharmaceuticals, Inc. || adults and pediatric patients 1 year and older with diffuse midline glioma (DMG) with H3 K27M mutation after progression following prior therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma | | | 26 || 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 Sunvozertinib (Zegfrovy)] || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B |
| |- | | |- |
| | 27 || 7/2/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 sunvozertinib (Zegfrovy)] || Dizal (Jiangsu) Pharmaceutical Co., Ltd. || adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 | | | 27 || 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 (≥4 prior lines, accelerated) || LINKER-MM1 |
| |- | | |- |
| | 28 || 7/2/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma linvoseltamab-gcpt (Lynozyfic)] || Regeneron Pharmaceuticals, Inc. || adult patients with relapsed or refractory multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma | | | 28 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018) |
| |- | | |- |
| | 29 || 6/23/2025 || Accelerated approval || [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, Inc. || adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) whose disease has progressed on or after treatment with an EGFR-directed therapy and platinum-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer | | | 29 || 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 Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1 |
| |- | | |- |
| | 30 || 6/18/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma tafasitamab-cxix (Monjuvi)] || Incyte Corporation || with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma | | | 30 || 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 with CIS || SunRISe-1 |
| |- | | |- |
| | 31 || 6/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck pembrolizumab (Keytruda)] || Merck || adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck | | | 31 || 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 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT |
| |- | | |- |
| | 32 || 6/12/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle mitomycin intravesical solution (Zusduri)] || UroGen Pharma || adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle | | | 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77 |
| |- | | |- |
| | 33 || 6/11/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer taletrectinib (Ibtrozi)] || Nuvation Bio Inc. || adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer | | | 33 || 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 Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3 |
| |- | | |- |
| | 34 || 6/3/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer darolutamide (Nubeqa)] || Bayer Healthcare Pharmaceuticals Inc. || adults with metastatic castration-sensitive prostate cancer (mCSPC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer | | | 34 || 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) + Atezolizumab (Tecentriq)] || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte |
| |- | | |- |
| | 35 || 5/15/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma retifanlimab-dlwr (Zynyz)] || Incyte Corporation || with carboplatin and paclitaxel for first-line treatment and as monotherapy for adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma | | | 35 || 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 (high-risk) || C-POST |
| |- | | |- |
| | 36 || 5/14/2025 || Accelerated approval || [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 Inc. || adult patients with locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression (IHC 3+) whose disease has progressed on or after systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression | | | 36 || 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)] || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8 |
| |- | | |- |
| | 37 || 5/14/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma belzutifan (Welireg)] || Merck & Co., Inc. || adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma | | | 37 || 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-mutated relapsed or refractory AML (adult & pediatric ≥1 year) || AUGMENT-101 |
| |- | | |- |
| | 38 || 5/8/2025 || Accelerated approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack)] || Verastem, Inc. || adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low | | | 38 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA |
| |- | | |- |
| | 39 || 4/23/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma penpulimab-kcqx] || Akeso Biopharma Co., Ltd. || adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma | | | 39 || 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 || NPM1-mutated relapsed or refractory AML || KOMET-001 |
| |- | | |- |
| | 40 || 4/11/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma nivolumab (Opdivo)] || Bristol Myers Squibb Company || nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma | | | 40 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies |
| |- | | |- |
| | 41 || 4/8/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer nivolumab (Opdivo)] || Bristol Myers Squibb Company || nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer | | | 41 || 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 (combo + monotherapy) || EPCORE FL-1 |
| |- | | |- |
| | 42 || 3/28/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer durvalumab (Imfinzi)] || AstraZeneca || durvalumab with gemcitabine and cisplatin as neoadjuvant treatment followed by durvalumab as adjuvant treatment after radical cystectomy for adults with muscle invasive bladder cancer (MIBC) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer | | | 42 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform Selumetinib (Koselugo)] || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT |
| |- | | |- |
| | 43 || 3/28/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication lutetium lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis Pharmaceuticals Corporation || adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication | | | 43 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA |
| |- | | |- |
| | 44 || 3/26/2025 || Approval || [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, Inc. || adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet | | | 44 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer Sevabertinib (Hyrnuo)] || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01 |
| |- | | |- |
| | 45 || 3/19/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma pembrolizumab (Keytruda)] || Merck || pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma | | | 45 || 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 small cell lung cancer (traditional approval) || DeLLphi-301 |
| |- | | |- |
| | 46 || 2/14/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor vimseltinib (Romvimza)] || Deciphera Pharmaceuticals, LLC || adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor | | | 46 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev)] || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303 |
| |- | | |- |
| | 47 || 2/12/2025 || Approval || [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 Inc. (subsidiary of Pfizer) || brentuximab vedotin with lenalidomide and rituximab for adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy who are ineligible for autologous HSCT or CAR T-cell therapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell | | | 47 || 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 (perioperative) || MATTERHORN |
| |- | | |- |
| | 48 || 2/11/2025 || Approval || [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 Therapeutics, Inc. || adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic | | | 48 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN |
| |- | | |- |
| | 49 || 2/6/2025 || Approval || [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 || treosulfan with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or | | | 49 || 2025-12-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL |
| |- | | |- |
| | 50 || 1/27/2025 || Approval || [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, Inc. || adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 | | | 50 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib + Abiraterone acetate (Akeega)] || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE |
| |- | | |- |
| | 51 || 1/17/2025 || Approval || [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, Inc. || adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast | | | 51 || 2025-12-15 || [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab] || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09 |
| |- | | |- |
| | 52 || 1/16/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer sotorasib (Lumakras)] || Amgen Inc. || adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer | | | 52 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3 |
| |- | | |- |
| | 53 || 1/16/2025 || Approval || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma acalabrutinib (Calquence)] || AstraZeneca || adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT) || Not specified in FDA list entry || https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma | | | 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer Rucaparib (Rubraca)] || pharma& GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3 |
| |} | | |} |
