Posted by Michael Wonder on 02 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer
2 July 2018 - Application based on data from pivotal Phase 3 KEYNOTE-407 trial.
Merck today announced that the U.S. FDA has accepted for review a supplemental biologics license application for Keytruda, 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 application, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology 2018 Annual Meeting.
The FDA has granted priority review to this application and set a Prescription Drug User Fee Act, or target action, date of 30 October 2018.
