The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for patritumab deruxtecan, an investigational treatment developed by Daiichi Sankyo and Merck. The BLA sought accelerated approval for patritumab deruxtecan to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received two or more systemic therapies.
The CRL was issued due to inspection findings at a third-party manufacturing facility. The FDA’s decision was not related to the efficacy or safety of patritumab deruxtecan. Daiichi Sankyo and Merck are working closely with the third-party manufacturer to address the inspection findings and resolve any issues to ensure compliance with Good Manufacturing Practices (GMP).
