KENILWORTH (NJ) (dpa-AFX) - 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.



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