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FDA Grants Priority Review for Daiichi Sankyo and Merck’s Patritumab Deruxtecan

Dec 22, 2023

Daiichi Sankyo and Merck announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date for its regulatory decision of 26 June 2024.