Merck's (MRK) Lung Cancer Candidate Faces FDA Rejection

Merck (MRK) and its partner Daiichi Sankyo announced that the FDA has issued a complete response letter (“CRL”) to the biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated non-small cell lung cancer (NSCLC).The BLA seeks approval for patritumab deruxtecan, a specifically engineered potential first-in-class HER3-directed DXd antibody drug conjugate (ADC), to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC pr ...