Health

FDA Rejects Merck-Daiichi Lung Cancer Drug

Jun 27, 2024 1 min read

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The U.S. Food and Drug Administration (FDA) has declined to approve the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd), an antibody-drug conjugate developed by Merck & Co. Inc. and Daiichi Sankyo, intended for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The decision was based on issues identified during an inspection of a third-party manufacturing facility, rather than any concerns about the efficacy or safety data submitted in the application.

Patritumab deruxtecan was part of a significant research and commercial collaboration between Merck and Daiichi Sankyo, valued at up to $22 billion. The companies plan to address the FDA's feedback and resolve the manufacturing issues in order to bring the drug to market. The rejection marks a setback for the potential first-in-class HER3-directed DXd antibody-drug conjugate, which aimed to serve patients who have failed two prior treatments and have tumors expressing a mutation leading to uncontrolled growth of the EGFR protein.

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