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FDA Oncology Approvals 2025: Difference between revisions

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{| class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Indication !! Clinical Trial Name |- | 1 || 2025-01-16 || Sotorasib (Lumakras) || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 2 || 2025-01-16 || Panitumumab (Vectibix) || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300 |- | 3 || 2025-01-16 || Acalabrutinib (Calquence) || Frontline treatment for Mantle Cell Lymphoma (MCL) || ECHO |- | 4 || 2025-01-17 || Datopotamab deruxtecan-dlnk (Datroway) || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01 |- | 5 || 2025-01-21 || Treosulfan (Grafapex) || Conditioning for allogeneic HSCT in AML/MDS || MC-FludT.14/L |- | 6 || 2025-02-10 || Amezalpat (TPST-1120) || First-line treatment of unresectable or metastatic HCC || Phase 1b/2 Study |- | 7 || 2025-02-11 || Mirdametinib (Gomekli) || NF1-associated plexiform neurofibromas || ReNeu |- | 8 || 2025-02-14 || Vimseltinib (Romvimza) || Tenosynovial giant cell tumor (TGCT) || MOTION |- | 9 || 2025-02-14 || Pembrolizumab (Keytruda) || First-line treatment for unresectable pleural mesothelioma || IND.227 |- | 10 || 2025-03-04 || Tislelizumab-jsgr (Tevimbra) || First-line PD-L1+ advanced esophageal squamous cell carcinoma || RATIONALE-306 |- | 11 || 2025-03-05 || Zanubrutinib (Brukinsa) || Relapsed or refractory follicular lymphoma (FL) || ROSEWOOD |- | 12 || 2025-03-12 || Nivolumab (Opdivo) || First-line metastatic urothelial carcinoma || CheckMate-901 |- | 13 || 2025-03-19 || Pembrolizumab (Keytruda) || Frontline treatment for HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma || KEYNOTE-811 |- | 14 || 2025-03-22 || Mirvetuximab soravtansine-gynx (Elahere) || FRα-positive, platinum-resistant ovarian cancer (Full Approval) || MIRASOL |- | 15 || 2025-03-26 || Cabozantinib (Cabometyx) || Pancreatic neuroendocrine tumors (pNETs) || CABINET |- | 16 || 2025-04-08 || Nivolumab + Ipilimumab (Opdivo + Yervoy) || MSI-H/dMMR metastatic colorectal cancer || CheckMate-8HW |- | 17 || 2025-04-10 || Ciltacabtagene autoleucel (Carvykti) || R/R Multiple Myeloma after at least one prior line || CARTITUDE-4 |- | 18 || 2025-04-11 || Nivolumab + Ipilimumab (Opdivo + Yervoy) || First-line unresectable/metastatic hepatocellular carcinoma || CheckMate-9DW |- | 19 || 2025-04-21 || Nivolumab + Ipilimumab (Opdivo + Yervoy) || Advanced Hepatocellular Carcinoma (HCC) || CheckMate-040 |- | 20 || 2025-04-23 || Penpulimab-kcqx || Recurrent or metastatic non-keratinizing nasopharyngeal carcinoma || AK105-302 |- | 21 || 2025-05-08 || Avutometinib + Defactinib (Avmapki/Fakzynja) || KRAS-mutated recurrent low-grade serous ovarian cancer || RAMP 201 |- | 22 || 2025-05-08 || Selpercatinib (Retevmo) || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121 |- | 23 || 2025-05-14 || Telisotuzumab vedotin-tllv (Emrelis) || c-Met high non-squamous metastatic NSCLC || LUMINOSITY |- | 24 || 2025-05-26 || Belzutifan (Welireg) || Advanced pheochromocytoma and paraganglioma (PPGL) || LITESPARK-013 |- | 25 || 2025-05-30 || Lisocabtagene maraleucel (Breyanzi) || Relapsed or refractory Mantle Cell Lymphoma (MCL) || TRANSCEND MCL |- | 26 || 2025-06-11 || Taletrectinib (Ibtrozi) || ROS1-positive locally advanced or metastatic NSCLC || TRUST-I |- | 27 || 2025-06-18 || Tafasitamab-cxix (Monjuvi) || Relapsed or refractory Follicular Lymphoma || inMIND |- | 28 || 2025-06-23 || Datopotamab deruxtecan-dlnk (Datroway) || EGFR-mutated locally advanced/metastatic NSCLC || TROPION-LUNG01 |- | 29 || 2025-06-27 || Durvalumab (Imfinzi) || dMMR advanced or recurrent endometrial cancer || DUO-E |- | 30 || 2025-07-02 || Sunvozertinib (Zegfrovy) || EGFR Exon 20 insertion mutant metastatic NSCLC || WU-KONG6 |- | 31 || 2025-07-02 || Linvoseltamab-gcpt (Lynozyfic) || Relapsed or refractory Multiple Myeloma || LINKER-MM1 |- | 32 || 2025-08-06 || Dordaviprone (Modeyso) || H3 K27M-mutated diffuse midline glioma || ONC201 |- | 33 || 2025-08-08 || Zongertinib (Hernexeos) || HER2 TKD-mutant metastatic non-squamous NSCLC || Beamion LUNG-1 |- | 34 || 2025-08-25 || Leuprolide mesylate (Camcevi) || Advanced prostate cancer (New 3-month formulation) || FP-001 LMIS |- | 35 || 2025-08-29 || Denosumab-nxxpb (Bilprevda) || Skeletal-related events in advanced malignancies || Biosimilar |- | 36 || 2025-09-09 || Gemcitabine intravesical (Inlexzo) || Non-muscle invasive bladder cancer || Bridge |- | 37 || 2025-09-10 || Selumetinib sulfate (Koselugo) || Adult NF1-associated plexiform neurofibroma || SPRINT |- | 38 || 2025-09-19 || Keytruda Qlex (Pembrolizumab subcutaneous) || All adult/pediatric solid tumor indications for Keytruda || MK-3475 |- | 39 || 2025-09-25 || Imlunestrant (Inluriyo) || ESR1-mutated ER+/HER2- advanced breast cancer || EMBER-3 |- | 40 || 2025-10-02 || Lurbinectedin + Atezolizumab (Zepzelca + Tecentriq) || Maintenance treatment for ES-SCLC || IMforte |- | 41 || 2025-10-08 || Cemiplimab (Libtayo) || Adjuvant treatment for high-risk cutaneous squamous cell carcinoma || C-POST |- | 42 || 2025-10-23 || Belantamab mafodotin-blmf (Blenrep) || Relapsed or refractory Multiple Myeloma triplets || DREAMM-7/8 |- | 43 || 2025-10-24 || Revumenib (Revuforj) || Relapsed/refractory AML with NPM1 mutation || AUGMENT-101 |- | 44 || 2025-11-13 || Ziftomenib (Komzifti) || R/R AML with susceptible NPM1 mutation || KOMET-001 |- | 45 || 2025-11-13 || Pertuzumab-dpzb (Poherdy) || HER2+ breast cancer (Interchangeable Biosimilar) || Biosimilar |- | 46 || 2025-11-18 || Epcoritamab-bysp (Epkinly) || R/R Follicular Lymphoma (Full Approval) || EPCORE NHL-1 |- | 47 || 2025-11-19 || Tarlatamab-dlle (Imdelltra) || Extensive stage SCLC (Full Approval) || DeLLphi-301 |- | 48 || 2025-11-19 || Sevabertinib (Hyrnuo) || HER2 TKD-mutant non-squamous metastatic NSCLC || SOHO-01 |- | 49 || 2025-11-19 || Daratumumab + Hyaluronidase (Darzalex Faspro) || Newly diagnosed light chain (AL) amyloidosis || AQUILA |- | 50 || 2025-11-25 || Durvalumab (Imfinzi) || Resectable gastric or GEJ adenocarcinoma || MATTERHORN |- | 51 || 2025-12-03 || Pirtobrutinib (Jaypirca) || Relapsed or refractory CLL/SLL (Full Approval) || BRUIN |- | 52 || 2025-12-04 || Lisocabtagene maraleucel (Breyanzi) || Relapsed or refractory Marginal Zone Lymphoma (MZL) || TRANSCEND |- | 53 || 2025-12-12 || Niraparib + Abiraterone (Akeega) || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE |- | 54 || 2025-12-17 || Amivantamab + Hyaluronidase (Rybrevant Faspro) || Subcutaneous delivery for all approved indications || PALOMA-3 |}
|+ FDA Approved Oncology Drugs in 2025
! Item Number !! 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 (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 || CodeBreK 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 (Calquence)] <br /> Bendamustine <br /> Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ECHO
|-
| 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 (Grafapex)] <br /> Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L
|-
| 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 || 2025-10-24 || [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
|-
| 12 || 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
|-
| 13 || 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
|-
| 14 || 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)] <br /> Abiraterone acetate || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE
|-
| 15 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab (Rybrevant Faspro)] <br /> Hyaluronidase-lpuj || Janssen || Subcutaneous formulation for NSCLC || PALOMA-3
|}

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