Ifinatamab deruxtecan (DS-7300) - (IDeate-Lung02 )

April 13, 2026: Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK) announced that the FDA accepted their Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd), a B7-H3–directed DXd antibody-drug conjugate, for treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after platinum-based chemotherapy. The FDA granted Priority Review, with a PDUFA (action) date of October 10, 2026, and is reviewing the filing under Real-Time Oncology Review (RTOR) and Project Orbis.

The submission is based on results from the IDeate-Lung01 Phase 2 trial, with supportive data from the IDeate-PanTumor01 Phase 1/2 trial. The primary analysis of IDeate-Lung01 was presented at the 2025 World Conference on Lung Cancer (WCLC25) and published in the Journal of Clinical Oncology (no efficacy/safety numbers included in the provided text). I-DXd previously received FDA Breakthrough Therapy Designation (August 2025) for the same ES-SCLC setting.

The company also notes ongoing Phase 3 trials: IDeate-Lung02 (SCLC), IDeate-Prostate01 (castration-resistant prostate cancer), and IDeate-Esophageal01 (esophageal squamous cell carcinoma).