Merck, Daiichi Sankyo Say FDA Grants Priority Review In U.S. For Patritumab Deruxtecan

(RTTNews) - Merck & Co. Inc. (MRK) and Japan's Daiichi Sankyo Co. Ltd. (DSKYF.PK) announced Friday that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial.