DAIICHI SANKYO, INC.

FDA issues Complete Response Letter for Daiichi Sankyo and Merck's patritumab deruxtecan BLA due to inspection findings at a third-party manufacturer, without issues identified with efficacy or safety data. Patritumab deruxtecan is a potential first-in-class HER3-directed ADC, jointly developed by Daiichi Sankyo and Merck, aiming to treat EGFR-mutated NSCLC patients previously treated with two or more systemic therapies.

Datopotamab deruxtecan's BLA accepted in the US for treating metastatic HR-positive, HER2-negative breast cancer, based on Phase III trial results showing significant PFS improvement over chemotherapy. FDA decision expected Q1 2025.