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FDA Oncology Approvals 2025: Difference between revisions

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{| class="wikitable sortable" |+ FDA Approved Oncology Drugs in 2025 ! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name |- | rowspan="2" | 1 || rowspan="2" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || rowspan="2" | Amgen || rowspan="2" | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy || rowspan="2" | CodeBreK 300 |- | [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] |- | rowspan="3" | 2 || rowspan="3" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || rowspan="3" | AstraZeneca || rowspan="3" | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT || rowspan="3" | ELEVATE-TN |- | Bendamustine |- | Rituximab |- | 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 unresectable or metastatic breast cancer || TROPION-Breast01 |- | rowspan="2" | 4 || rowspan="2" | 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)] || rowspan="2" | medac GmbH || rowspan="2" | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS || rowspan="2" | MC-FludT.14/L Trial II |- | Fludarabine |- | 5 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromitosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 6 || 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 || MOTION |- | 7 || 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 |- | rowspan="2" | 8 || rowspan="2" | 2025-05-08 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Avutometinib (Avmapki)] || rowspan="2" | Verastem || rowspan="2" | KRAS-mutated low-grade serous ovarian cancer (LGSOC) || rowspan="2" | RAMP 201 |- | Defactinib (Fakzynja) |- | 9 || 2025-05-14 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous NSCLC || LUMINOSITY |- | 10 || 2025-06-11 || [https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025 Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive non-small cell lung cancer || TRUST-I |- | 11 || 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 |- | 12 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals Dordaviprone (Modeyso)] || Chimerix || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 13 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Imlunestrant (Inluriyo)] || Eli Lilly || ER+/HER2- ESR1-mutated advanced breast cancer || EMBER-3 |- | 14 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed/refractory AML || AUGMENT-101 |- | 15 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 16 || 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 || Traditional Approval: Relapsed or refractory CLL/SLL || BRUIN |- | rowspan="2" | 17 || rowspan="2" | 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 (Akeega)] || rowspan="2" | Janssen || rowspan="2" | BRCA2-mutated metastatic castration-sensitive prostate cancer || rowspan="2" | MAGNITUDE |- | Abiraterone acetate |- | rowspan="2" | 18 || rowspan="2" | 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab (Rybrevant Faspro)] || rowspan="2" | Janssen || rowspan="2" | Subcutaneous injection for all approved amivantamab indications || rowspan="2" | PALOMA-3 |- | Hyaluronidase-lpuj |}
{| class="wikitable sortable" |+ FDA Approved Oncology Drugs in 2025 ! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name |- | rowspan="2" | 1 || rowspan="2" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || rowspan="2" | Amgen || rowspan="2" | KRAS G12C–mutated metastatic colorectal cancer || rowspan="2" | CodeBreaK 300 |- | [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] |- | rowspan="3" | 2 || rowspan="3" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || rowspan="3" | AstraZeneca || rowspan="3" | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT || rowspan="3" | ECHO |- | Bendamustine |- | Rituximab |- | 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 |- | rowspan="2" | 4 || rowspan="2" | 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)] || rowspan="2" | medac GmbH || rowspan="2" | Conditioning for allogeneic HSCT in AML or MDS || rowspan="2" | MC-FludT.14/L |- | Fludarabine |- | 5 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromitosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 6 || 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 || MOTION |- | 7 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line metastatic pleural mesothelioma || IND.227 |- | 8 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous NSCLC || LUMINOSITY |- | 9 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 10 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutant metastatic NSCLC || Beamion LUNG-1 |- | 11 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-advanced-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced breast cancer || EMBER-3 |- | 12 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 13 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001 |- | 14 || 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 || Traditional Approval: Relapsed or refractory CLL/SLL || BRUIN |- | rowspan="2" | 15 || rowspan="2" | 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 (Akeega)] || rowspan="2" | Janssen || rowspan="2" | BRCA2-mutated metastatic castration-sensitive prostate cancer || rowspan="2" | MAGNITUDE |- | Abiraterone acetate |}

Revision as of 00:04, 1 January 2026

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