Overview
- Merck and Daiichi Sankyo said the FDA accepted their biologics application and set an October 10, 2026 decision date for ifinatamab deruxtecan.
- The filing seeks approval for adults with extensive-stage small cell lung cancer whose disease worsened after platinum chemotherapy, a group with few effective options today.
- The review uses two fast-track tools: Real-Time Oncology Review, which lets the FDA assess data as they come in, and Project Orbis, which supports parallel reviews with partner countries.
- The submission rests on the Phase II IDeate-Lung01 trial, which reported a 48.2% confirmed response rate, with added support from the Phase I/II IDeate-PanTumor01 study.
- Ifinatamab deruxtecan targets B7-H3 and delivers a chemotherapy payload directly to tumor cells, and it received FDA Breakthrough Therapy designation in August 2025.