The FDA has said it cannot approve MSD and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate (ADC) patritumab deruxtecan because of problems at a third-party manufacturer.A complete response letter from the US regulator indicated that it had uncovered compliance issues during an inspection of the facility that meant it was unable to clear the ADC as a third-line or later treatment for adults with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer (NSCLC).
