Posted by Michael Wonder on 11 Jan 2017
Merck receives FDA acceptance of supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer
10 January 2017 - Submission based on data from KEYNOTE-021 trial, cohort G, which enrolled patients regardless of PD-L1 expression.
Merck today announced that the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumour aberrations.
This is the first application for regulatory approval of Keytruda in combination with another treatment. The FDA granted priority review with a PDUFA, or target action, date of 10 May 2017. The application will be reviewed under the FDA’s accelerated approval program.
