Keytruda plus carboplatin-paclitaxel or nab-paclitaxel filed with FDA for metastatic squamous non-small cell lung cancer.- Merck Inc.

Merck Inc. announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase III KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2018.

The application is based on data frm the Phase III KEYNOTE-407 trial which met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with Keytruda in combination with chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone. The safety profile of Keytruda in this combination was consistent with that previously observed in lung cancer.