Priority Review for Keytruda in broad NSCLC indication

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab in a broader first-line non-small cell lung cancer indication than that for which the drug is already approved. The PDUFA date is May 10 for the NDA, which will be reviewed under FDA's accelerated approval program.

The sBLA is seeking approval of Keytruda plus chemotherapy as first-line treatment for metastatic or advanced non-squamous NSCLC regardless of PD-L1 expression in patients without EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations...