Keytruda pembrolizumab regulatory update

Merck submitted an sBLA to FDA for Keytruda pembrolizumab to treat advanced non-small cell lung cancer (NSCLC). The application covers patients whose disease has progressed on or after platinum-containing chemotherapy or a therapy for EGFR or anaplastic lymphoma kinase (ALK) tumor aberrations. The humanized IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) has breakthrough therapy designation in the U.S. for advanced NSCLC. ...