Daiichi and Merck pull patritumab deruxtecan BLA

29 May 2025

Japan’s Daiichi Sankyo (TYO: 4568) and partner Merck & Co (NYSE: MRK) today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn.

The decision to withdraw the BLA is based on top-line overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase III trial where OS did not meet statistical significance as well as discussions with the U.S. Food and Drug Administration.

The companies noted that the decision is unrelated to the complete response letter (CRL) that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility.

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