MRK - FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug | Benzinga
On Wednesday, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and Merck & Co Inc’s (NYSE:MRK) patritumab deruxtecan (HER3-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
The CRL results from findings about an inspection of a third-party manufacturing facility.
The CRL did not identify any issues with the efficacy or safety data ...