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| {| class="wikitable sortable" | | {| class="wikitable sortable" |
| ! 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-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 || 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-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO |
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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-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 || 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-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 || 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 (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic 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-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || 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 || 2025-02-11 || [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 || 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-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || 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 || 2025-03-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Tislelizumab-jsgr (Tevimbra)] || BeiGene || First-line esophageal squamous cell carcinoma || RATIONALE-306 |
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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 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zanubrutinib (Brukinsa)] || BeiGene || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |
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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 || 2025-03-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Dabrafenib (Tafinlar)] || Novartis || Pediatric BRAF-mutant melanoma || N/A |
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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 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate-901 |
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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 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Binimetinib (Mektovi)] || Pfizer || Metastatic NSCLC || N/A |
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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 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Encorafenib (Braftovi)] || Pfizer || Metastatic NSCLC || N/A |
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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 || 2025-03-19 || [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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| | 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 || 2025-03-26 || [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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| | 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 || 2025-03-28 || [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 |
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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 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Neoadjuvant/adjuvant muscle invasive bladder cancer || NIAGARA |
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| | 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 || 2025-04-08 || [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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| | 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 || 2025-04-09 || [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 |
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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 || 2025-04-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Larotrectinib (Vitrakvi)] || Bayer || NTRK gene fusion solid tumors || NAVIGATE |
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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 || 2025-04-11 || [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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| | 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 || 2025-04-23 || [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 |
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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 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Palbociclib (Ibrance)] || Pfizer || Expanded indications for breast cancer || PALOMA-2 |
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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 || 2025-05-08 || [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 |
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| | 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 || 2025-05-08 || [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 |
| |- | | |- |
| | 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 || 2025-05-14 || [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 |
| |- | | |- |
| | 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 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma (PPGL) || LITESPARK-013 |
| |- | | |- |
| | 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 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell anal carcinoma || POD1UM-303 |
| |- | | |- |
| | 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 || 2025-05-30 || [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 |
| |- | | |- |
| | 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 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer || ARANOTE |
| |- | | |- |
| | 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 || 2025-06-11 || [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 |
| |- | | |- |
| | 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 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Pembrolizumab (Keytruda)] || Merck || Resectable locally advanced HNSCC || KEYNOTE-689 |
| |- | | |- |
| | 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 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Mitomycin (Zusduri)] || UroGen || Recurrent low-grade intermediate-risk NMIBC || ENVISION |
| |- | | |- |
| | 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 || 2025-06-18 || [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 |
| |- | | |- |
| | 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 || 2025-06-23 || [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 |
| |- | | |- |
| | 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 || 2025-06-27 || [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 |
| |- | | |- |
| | 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 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Sunvozertinib (Zegfrovy)] || Dizal || EGFR Exon 20 insertion mutant NSCLC || WU-KONG6 |
| |- | | |- |
| | 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 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma || LINKER-MM1 |
| |- | | |- |
| | 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 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Jazz || H3 K27M-mutated progressive diffuse midline glioma || ONC201 |
| |- | | |- |
| | 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 || 2025-08-08 || [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 |
| |- | | |- |
| | 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 || 2025-08-25 || [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 |
| |- | | |- |
| | 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 || 2025-09-09 || [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 |
| |- | | |- |
| | 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 || 2025-09-10 || [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 |
| |- | | |- |
| | 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 || 2025-09-19 || [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 |
| |- | | |- |
| | 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 || 2025-09-25 || [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 |
| |- | | |- |
| | 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 || 2025-10-02 || [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 |
| |- | | |- |
| | 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 || 2025-10-08 || [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 |
| |- | | |- |
| | 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 || 2025-10-23 || [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 |
| |- | | |- |
| | 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 || 2025-11-06 || [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 |
| |- | | |- |
| | 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 || 2025-11-13 || [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 |
| |- | | |- |
| | 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 || 2025-12-03 || [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 |
| |- | | |- |
| | 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-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab subcutaneous (Rybrevant Faspro)] || Janssen || Subcutaneous delivery for all indications || PALOMA-3 |
| |} | | |} |
