Lead Daiichi/Merck ADC Collab HER3-DXd Hit With CRL

Manufacturing Findings

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.

The CRL is related to the inspection of a third-party manufacturer, Daiichi Sankyo and Merck noted.
patritumab CRL related to inspection of third-party manufacturer • Source: Shutterstock

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