Oncology FDA Approval– category –

[FDA Accelerated Approval] New Oral TKI for Advanced NSCLC with EGFR Exon20 Insertions On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (brand name: Zegfrovy) for the treatment of adult patients with locally advance...

[FDA Approval] BCMA/CD3 Bispecific Antibody Approved on July 2, 2025 On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab (brand name: Lynozyfic) for the treatment of adults with rela...

[FDA Accelerated Approval] Datroway by Daiichi Sankyo approved for EGFR-mutated non-small cell lung cancer (June 23, 2025) On June 23, 2025, the U.S. FDA granted accelerated approval to Datopotamab deruxtecan-dlnk (Datroway) for adults w...

[FDA Approval Alert] Tisotumab vedotin-tftv by Seagen and Genmab approved for recurrent/metastatic cervical cancer (June 21, 2025) On June 21, 2025, the U.S. FDA approved Tisotumab vedotin-tftv (Tivdak) for the treatment of recurrent or ...

【FDA Approval Alert】medac's treosulfan (Grafapex) Approved for Conditioning in AML/MDS allo-HSCT (January 21, 2025) On January 21, 2025, the U.S. FDA approved treosulfan (Grafapex) in combination with fludarabine as part of a condition...

FDA Approval Alert: Merck's pembrolizumab (Keytruda) Approved for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (June 12, 2025) On June 12, 2025, the FDA approved pembrolizumab (Keytruda) for the treatment of resectab...

【FDA Approval Alert】UroGen Pharma's mitomycin (Zusduri) Approved for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (June 12, 2025) On June 12, 2025, the U.S. FDA approved mitomycin (Zusduri) for adult patient...

【FDA Approval Alert】Nuvation Bio's taletrectinib (Ibtrozi) Approved for ROS1-Positive Non-Small Cell Lung Cancer (June 11, 2025) On June 11, 2025, the U.S. FDA approved taletrectinib (Ibtrozi) for adult patients with locally advanced o...

【FDA Approval Alert】Bayer's darolutamide (Nubeqa) Approved for Metastatic Castration-Sensitive Prostate Cancer (June 3, 2025) On June 3, 2025, the U.S. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate can...

【FDA Approval Alert】Incyte's retifanlimab-dlwr (Zynyz) Approved for Squamous Cell Carcinoma of the Anal Canal (May 15, 2025) On May 15, 2025, the U.S. FDA approved retifanlimab-dlwr (Zynyz) for adults with inoperable locally recurrent ...

【FDA Approval Alert】AbbVie's telisotuzumab vedotin-tllv (Emrelis) Accelerated Approval for High c-Met Non-Small Cell Lung Cancer (May 14, 2025) On May 14, 2025, the U.S. FDA granted accelerated approval to telisotuzumab vedotin-tllv (E...

【FDA Approval Alert】Merck's belzutifan (Welireg) Approved for Pheochromocytoma and Paraganglioma (May 14, 2025) On May 14, 2025, the U.S. FDA approved belzutifan (Welireg) for patients aged 12 years and older with locally advanced, unr...

【FDA Approval Alert】Verastem's avutometinib + defactinib Approved for KRAS-Mutated Low-Grade Serous Ovarian Cancer (May 8, 2025) On May 8, 2025, the U.S. FDA granted accelerated approval to avutometinib + defactinib (Avmapki Fakzynja C...

【FDA Approval Alert】Akeso's penpulimab-kcqx Approved for Non-Keratinizing Nasopharyngeal Carcinoma (April 23, 2025) On April 23, 2025, the U.S. FDA approved penpulimab-kcqx (Akeso) for adult patients with recurrent or metastatic non-ke...

【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for Advanced Hepatocellular Carcinoma (April 11, 2025) On April 11, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatm...

【FDA Approval Alert】Bristol Myers Squibb's nivolumab + ipilimumab Approved for MSI-H/dMMR Colorectal Cancer (April 8, 2025) On April 8, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for adults and pediatric pa...

【FDA Approval Alert】AstraZeneca's durvalumab (Imfinzi) Approved for Muscle-Invasive Bladder Cancer (March 28, 2025) On March 28, 2025, the U.S. FDA approved durvalumab (Imfinzi) for adult patients with muscle-invasive bladder cancer (M...

【FDA Approval Alert】Novartis's Pluvicto Indication Expanded for PSMA-Positive mCRPC (March 28, 2025) On March 28, 2025, the U.S. FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to include adults with PS...

【FDA Approval Alert】Exelixis's cabozantinib (Cabometyx) Approved for pNET and epNET (March 26, 2025) On March 26, 2025, the U.S. FDA approved cabozantinib (Cabometyx) for adults and pediatric patients 12 years and older with previously...

【FDA Approval Alert】Merck's pembrolizumab (Keytruda) Approved for HER2-Positive PD-L1 CPS ≥1 Gastric and GEJ Adenocarcinoma (March 19, 2025) On March 19, 2025, the U.S. FDA granted regular approval to pembrolizumab (Keytruda) in combin...