Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer
FDA issues Complete Response Letter for Daiichi Sankyo and Merck's patritumab deruxtecan BLA due to inspection findings at a third-party manufacturer, without issues identified with efficacy or safety data. Patritumab deruxtecan is a potential first-in-class HER3-directed ADC, jointly developed by Daiichi Sankyo and Merck, aiming to treat EGFR-mutated NSCLC patients previously treated with two or more systemic therapies.
Highlighted Terms
Related News
FDA issues Complete Response Letter for Daiichi Sankyo and Merck's patritumab deruxtecan BLA due to inspection findings at a third-party manufacturer, without issues identified with efficacy or safety data. Patritumab deruxtecan is a potential first-in-class HER3-directed ADC, jointly developed by Daiichi Sankyo and Merck, aiming to treat EGFR-mutated NSCLC patients previously treated with two or more systemic therapies.