Posted by Michael Wonder on 01 May 2018
FDA grants priority review to Merck’s sBLA for Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy based on results from Phase 3 KEYNOTE-189 trial as first-line treatment of metastatic non-squamous NSCLC
30 April 2018 - U.S. FDA has set a PDUFA date of 23 September 2018.
Merck today announced that the U.S. FDA has accepted for review a supplemental biologics license application for Keytruda, the company’s anti-PD-1 therapy, based on results of the Phase 3 KEYNOTE-189 trial.
The application seeks approval for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA has granted priority review to this application and has set a Prescription Drug User Fee Act, or target action, date of 23 September 2018.
