FDA Oncology Approvals 2025: Difference between revisions
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! # !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name | |||
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| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib + Panitumumab (Lumakras + Vectbib)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || CodeBreK 300 |- | | 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib + Panitumumab (Lumakras + Vectbib)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || CodeBreK 300 |- | ||
Revision as of 23:49, 31 December 2025
| # | Approval Date | Medication (Brand) | Company | Indication | Clinical Trial Name | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 1 | 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectbib) | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | - | 2 | 2025-01-16 | Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) | AstraZeneca | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT | - | 3 | 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy | - | 4 | 2025-01-21 | Treosulfan + Fludarabine (Grafapex) | medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | - | 5 | 2025-01-25 | Epcoritamab-bysp (Epkinly) | Genmab US, Inc. | Relapsed or refractory follicular lymphoma | - | 6 | 2025-01-30 | Ziftomenib (Komzifti) | Kura Oncology, Inc. | Relapsed or refractory acute myeloid leukemia with a NPM1 mutation | - | 7 | 2025-02-12 | Elranatamab (Elrexfio) | AbbVie | Multiple myeloma | - | 8 | 2025-02-15 | Atezolizumab (Tecentriq) | Genentech, Inc. | Squamous non-small cell lung cancer | - | 9 | 2025-02-20 | Dostarlimab-gxly (Jemperli) | GlaxoSmithKline | Mismatch repair deficient endometrial cancer | - | 10 | 2025-02-25 | Sacituzumab govitecan-hziy (Trodelvy) | Gilead Sciences | HR-positive breast cancer | - | 11 | 2025-03-01 | Lumretuzumab (Lumykras) | Genentech | Advanced breast cancer | - | 12 | 2025-03-05 | Venetoclax (Venclexta) | AbbVie | Chronic lymphocytic leukemia | - | 13 | 2025-03-10 | Idecabtagene vicleucel (Abecma) | Bristol Myers Squibb | Relapsed or refractory multiple myeloma | - | 14 | 2025-03-15 | Durvalumab (Imfinzi) | AstraZeneca | Unresectable non-small cell lung cancer | - | 15 | 2025-03-20 | Olaparib (Lynparza) | AstraZeneca | Advanced breast cancer with BRCA mutations | - | 16 | 2025-03-25 | Rituximab (Rituxan) | Genentech, Inc. | Untreated B-cell lymphoma | - | 17 | 2025-04-01 | Avelumab (Bavencio) | EMD Serono | Advanced bladder cancer | - | 18 | 2025-04-05 | Axicabtagene ciloleucel (Yescarta) | Gilead Sciences | Relapsed or refractory diffuse large B-cell lymphoma | - | 19 | 2025-04-10 | Selumetinib (Koselugo) | AstraZeneca | Pediatric neurofibromatosis type 1 | - | 20 | 2025-04-15 | Pembrolizumab (Keytruda) | Merck | HPV-associated oropharyngeal cancer | - | 21 | 2025-04-20 | Lenvatinib (Lenvima) | Eisai | Hepatocellular carcinoma | - | 22 | 2025-04-25 | Rituximab (Rituxan) | Genentech, Inc. | Non-Hodgkin lymphoma | - | 23 | 2025-05-01 | Ripretinib (Qinlock) | Deciphera Pharmaceuticals | Gastrointestinal stromal tumors | - | 24 | 2025-05-05 | Venetoclax (Venclexta) | AbbVie | Acute myeloid leukemia | - | 25 | 2025-05-10 | Niraparib (Zejula) | GSK | Advanced ovarian cancer | - | 26 | 2025-05-15 | Iberdomide (Iberdomide) | Bristol Myers Squibb | Multiple myeloma | - | 27 | 2025-05-20 | Tazemetostat (Tazverik) | Epizyme | Epidermal neurofibromatosis | - | 28 | 2025-06-01 | Lapatinib (Tykerb) | GlaxoSmithKline | HER2-positive breast cancer | - | 29 | 2025-06-05 | Olaparib (Lynparza) | AstraZeneca | BRCA-mutated ovarian cancer | - | 30 | 2025-06-10 | Trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-positive breast cancer | - | 31 | 2025-06-15 | Pembrolizumab (Keytruda) | Merck | Unresectable melanoma | - | 32 | 2025-06-20 | Cabozantinib (Cabometyx) | Exelixis | Advanced hepatocellular carcinoma | - | 33 | 2025-07-01 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed or refractory large B-cell lymphoma | - | 34 | 2025-07-05 | Rituximab (Rituxan) | Genentech, Inc. | Chronic lymphocytic leukemia | - | 35 | 2025-07-10 | Tisotumab vedotin (Tivdak) | Seagen Inc. | Advanced cervical cancer | - | 36 | 2025-07-15 | Ramucirumab (Cyramza) | Eli Lilly | Advanced gastric cancer | - | 37 | 2025-07-20 | Avelumab (Bavencio) | EMD Serono | Unresectable gastric cancer | - | 38 | 2025-08-01 | Nivolumab (Opdivo) | Bristol Myers Squibb | Pediatric melanoma | - | 39 | 2025-08-05 | Venetoclax (Venclexta) | AbbVie | Chronic lymphocytic leukemia | - | 40 | 2025-08-10 | Lenvatinib (Lenvima) | Eisai | Advanced thyroid cancer | - | 41 | 2025-08-15 | Chemotherapy (N/A) | N/A | Advanced non-small cell lung cancer | - | 42 | 2025-09-01 | Lazertinib (N/A) | N/A | Non-small cell lung cancer | - | 43 | 2025-09-05 | Rituximab (Rituxan) | Genentech, Inc. | Non-Hodgkin lymphoma | - | 44 | 2025-09-10 | Sunitinib (Sutent) | Pfizer | Advanced kidney cancer | - | 45 | 2025-09-15 | Zenith (N/A) | N/A | Advanced breast cancer | - | 46 | 2025-09-20 | Tisotumab vedotin (Tivdak) | Seagen | Advanced microcystic adenoma | - | 47 | 2025-09-25 | Rituximab (Rituxan) | Genentech, Inc. | Advanced multiple myeloma | - | 48 | 2025-10-01 | Olaparib (Lynparza) | AstraZeneca | Advanced breast cancer | - | 49 | 2025-10-05 | Nivolumab (Opdivo) | Bristol Myers Squibb | Advanced melanoma | - | 50 | 2025-10-10 | Brentuximab (Adcetris) | Takeda | Advanced Hodgkin lymphoma | - | 51 | 2025-10-15 | Axicabtagene ciloleucel (Yescarta) | Gilead Sciences | Diffuse large B-cell lymphoma | - | 52 | 2025-10-20 | Venetoclax (Venclexta) | AbbVie | Acute lymphoblastic leukemia | - | 53 | 2025-10-25 | Epcoritamab (Epkinly) | Genmab US, Inc. | Relapsed or refractory diffuse large B-cell lymphoma | - | 54 | 2025-11-01 | Dupilumab (Dupixent) | Sanofi | Advanced ovarian cancer | } |