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

Manufacturing Findings

 
• By Ian Haydock and Lisa Takagi

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

Daiichi Sankyo Co., Ltd./Merck & Co., Inc.’s first collaborative antibody-drug conjugate (ADC) asset, patritumab deruxtecan (HER3-DXd), has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA), the two firms disclosed on 26 June, the original action date under the Prescription Drug User Fee Act (PDUFA).

The CRL for the potentially first-in-class HER3-targeting therapy was related solely to (unspecified) findings in an inspection of a third-party manufacturing partner and “did not identify any issues with the...

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