FDA Grants Priority Review to Ifinatamab Deruxtecan for Small Cell Lung Cancer Treatment
The U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for ifinatamab deruxtecan, a potential first-in-class B7-H3 directed DXd antibody drug conjugate developed by Daiichi Sankyo and Merck. This investigational drug is intended for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy. The Priority Review status indicates that the FDA sees significant potential for the drug to improve treatment outcomes compared to existing options. The application is also being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, which aim to expedite the availability of effective cancer treatments. The Prescription Drug User Fee Act (PDUFA) date for the FDA's decision is set for October 10, 2026. 
