Merck & Co. (MRK) announced that the FDA has accepted for review its supplemental Biologics License Application (sBLA) seeking approval of the use of KEYTRUDA (pembrolizumab) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, a Breakthrough Therapy designation. The agency's action date (PDUFA) is December 24. The data supporting the application was generated in the Phase 3 KEYNOTE-024 study which showed KEYTRUDA monotherapy demonstrated superior progression-free survival and overall survival compared to standard chemo. The company has filed a marketing application in Europe for the same indication.