MRK - Merck's Lung Cancer Candidate Faces FDA Rejection | Benzinga
Merck (NYSE: 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, to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with two or more systemic therapies.
The FDA's CRL was based on observations made after the inspection of a third-party manufacturing facility. The FDA has not requested any additional efficacy/safety studies, nor has it identified any issues related to the safety and efficacy of the candidate. Merck said it will work closely with the FDA and the third-party manufacturer to resolve the issue.
The BLA was supported by data from the HERTHENA-Lung01 pivotal phase II study. The study demonstrated an objective response rate of 29.8%, while the median duration of response (DoR) was 6.4 months.
Merck's ...