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| {| class="wikitable sortable" |+ FDA Oncology Approvals 2025 ! # !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name |- | 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 + Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib + Bendamustine + Rituximab (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ELEVATE-TN |- | 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 |- | 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 + Fludarabine (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L |- | 5 || 2025-01-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma || EPCORE NHL-1 |- | 6 || 2025-01-30 || [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 |- | 7 || 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 |- | 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 || MOTION |- | 9 || 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 unresectable pleural mesothelioma || IND.227 |- | 10 || 2025-02-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-neoadjuvant-and-adjuvant-treatment-resectable-non-small-cell-lung-cancer Durvalumab (Imfinzi)] || AstraZeneca || Resectable non-small cell lung cancer || AEGEAN |- | 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-obinutuzumab-relapsed-or-refractory-follicular-lymphoma Zanubrutinib (Brukinsa)] || BeiGene || R/R follicular lymphoma with obinutuzumab || ROSEWOOD |- | 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-cisplatin-and-gemcitabine-first-line-treatment-unresectable-or-metastatic Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate -901 |- | 13 || 2025-03-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fr-alpha-positive-platinum-resistant-epithelial-ovarian Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive platinum-resistant ovarian cancer || MIRASOL |- | 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome-positive-acute Ponatinib (Iclusig)] || Takeda || Newly diagnosed Ph+ ALL || PhALLCON |- | 15 || 2025-04-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tislelizumab-jsgr-unresectable-or-metastatic-esophageal-squamous-cell-carcinoma Tislelizumab-jsgr (Tevimbra)] || BeiGene || Metastatic esophageal squamous cell carcinoma || RATIONALE-302 |- | 16 || 2025-04-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-relapsed-or-refractory-multiple-myeloma-0 Idecabtagene vicleucel (Abecma)] || BMS || Relapsed/refractory multiple myeloma (earlier line) || KarMMa-3 |- | 17 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R multiple myeloma after one prior line || CARTITUDE-4 |- | 18 || 2025-04-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-low-or-her2-ultralow Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06 |- | 19 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutathera-pediatric-patients-12-years-and-older-gep-nets Lutathera] || Novartis || Pediatric patients with GEP-NETs || NETTER-P |- | 20 || 2025-04-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer Tisotumab vedotin-tftv (Tivdak)] || Seagen || Recurrent or metastatic cervical cancer || innovaTV 301 |- | 21 || 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 |- | 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-relapsed-or-refractory-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || R/R renal cell carcinoma with nivolumab || TiNivo-2 |- | 23 || 2025-05-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-chemotherapy-non-small-cell-lung-cancer-ex20ins-mutations Amivantamab-vmjw (Rybrevant)] || Janssen || NSCLC with EGFR Exon 20 insertion mutations || PAPILLON |- | 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL |- | 25 || 2025-06-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-combination-pembrolizumab-recurrent-or-metastatic-endometrial-cancer Selinexor (Xpovio)] || Karyopharm || Recurrent or metastatic endometrial cancer || SIENDO |- | 26 || 2025-06-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-cd19-positive-b-cell-precursor-acute-lymphoblastic-leukemia Blinatumomab (Blincyto)] || Amgen || CD19-positive B-cell precursor ALL || E1910 |- | 27 || 2025-06-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-adagrasib-combination-cetuximab-kras-g12c-mutated-colorectal-cancer Adagrasib (Krazati)] || BMS || KRAS G12C-mutated colorectal cancer || KRYSTAL-1 |- | 28 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-chemotherapy-endometrial-cancer Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E |- | 29 || 2025-07-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-endometrial-cancer Pembrolizumab (Keytruda)] || Merck || Primary advanced or recurrent endometrial cancer || KEYNOTE-868 |- | 30 || 2025-07-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Epcoritamab-bysp (Epkinly)] || Genmab || R/R DLBCL after failure of CAR-T || EPCORE NHL-1 |- | 31 || 2025-07-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma Belzutifan (Welireg)] || Merck || Advanced renal cell carcinoma || LITESPARK-005 |- | 32 || 2025-07-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma Vorasidenib (Voranigo)] || Servier || Grade 2 astrocytoma or oligodendroglioma || INDIGO |- | 33 || 2025-08-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-hyaluronidase-fihj-combination-bortezomib-lenalidomide-and-dexamethasone Daratumumab + Hyaluronidase (Darzalex Faspro)] || Janssen || Newly diagnosed multiple myeloma (transplant-eligible) || PERSEUS |- | 34 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-afatinib-pediatric-patients-six-years-and-older-advanced-solid-tumors Afatinib (Gilotrif)] || Boehringer Ingelheim || Pediatric advanced solid tumors with ErbB mutations || Study 1200.120 |- | 35 || 2025-08-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-relapsed-or-refractory-indolent-non-hodgkin-lymphoma Axicabtagene ciloleucel (Yescarta)] || Kite || R/R indolent Non-Hodgkin Lymphoma || ZUMA-5 |- | 36 || 2025-08-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-combination-amivantamab-vmjw-first-line-treatment-locally-advanced Lazertinib (Leclaza)] || Janssen || First-line EGFR-mutated NSCLC || MARIPOSA |- | 37 || 2025-08-29 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-pediatric-patients-one-year-and-older-relapsed-or-refractory Inotuzumab ozogamicin (Besponsa)] || Pfizer || Pediatric R/R B-cell precursor ALL || Study B1931022 |- | 38 || 2025-09-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-pemetrexed-and-platinum-chemotherapy-first-line-treatment Pembrolizumab (Keytruda)] || Merck || First-line malignant pleural mesothelioma || KEYNOTE-483 |- | 39 || 2025-09-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-resected-esophageal-or-gastroesophageal-junction-cancer Nivolumab (Opdivo)] || BMS || Adjuvant resected ESCC || CheckMate -577 |- | 40 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-venetoclax-previously-untreated-chronic-lymphocytic-leukemia Zanubrutinib (Brukinsa)] || BeiGene || Untreated CLL/SLL with venetoclax || SEQUOIA |- | 41 || 2025-09-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung Selpercatinib (Retevmo)] || Eli Lilly || RET fusion-positive NSCLC || LIBRETTO-431 |- | 42 || 2025-10-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-pediatric-patients-older-one-month-ntrk-fusion-positive-solid-tumors Entrectinib (Rozlytrek)] || Genentech || Pediatric NTRK fusion-positive solid tumors || STARTRK-NG |- | 43 || 2025-10-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trametinib-combination-dabrafenib-pediatric-patients-low-grade-glioma Trametinib (Mekinist)] || Novartis || Pediatric low-grade glioma with BRAF V600E || Study G2201 |- | 44 || 2025-10-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-gemcitabine-and-cisplatin-locally-advanced-or-metastatic Pembrolizumab (Keytruda)] || Merck || Advanced or metastatic biliary tract cancer || KEYNOTE-966 |- | 45 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-doxorubicin-relapsed-small-cell-lung-cancer Lurbinectedin (Zepzelca)] || Jazz Pharma || Relapsed small cell lung cancer || LAGOON |- | 46 || 2025-10-31 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-previously-treated-metastatic-colorectal-cancer Fruquintinib (Fruzaqla)] || Takeda || Refractory metastatic colorectal cancer || FRESCO-2 |- | 47 || 2025-11-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-combination-fulvestrant-advanced-hr-positive-her2-negative-breast-cancer Capivasertib (Truqap)] || AstraZeneca || HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations || CAPItello-291 |- | 48 || 2025-11-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-locally-advanced-or-metastatic-ros1-positive-non-small-cell-lung-cancer Repotrectinib (Augtyro)] || BMS || ROS1-positive metastatic NSCLC || TRIDENT-1 |- | 49 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-adult-patients-progressing-desmoid-tumors Nirogacestat (Ogsiveo)] || SpringWorks || Progressing desmoid tumors || DeFi |- | 50 || 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 NSCLC (perioperative) || AEGEAN |- | 51 || 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/SLL after BTK and BCL-2 inhibitors || BRUIN |- | 52 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Belzutifan (Welireg)] || Merck || Advanced clear cell renal cell carcinoma || LITESPARK-005 |- | 53 || 2025-12-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-second-line-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || Second-line renal cell carcinoma || TiNivo-2 |- | 54 || 2025-12-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-first-line-advanced-gastric-cancer Pembrolizumab (Keytruda)] || Merck || First-line HER2-negative gastric cancer || KEYNOTE-859 |} | | {| 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 |} |
