Posted by Michael Wonder on 11 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of patients with advanced hepatocellular carcinoma
11 July 2018 - Application based on monotherapy data from phase 2 KEYNOTE-224 trial.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application seeking approval for Keytruda, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma.
This application, which is seeking accelerated approval for this new indication, is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology Annual Meeting and published simultaneously in The Lancet Oncology. The FDA has set a Prescription Drug User Fee Act, or target action, date of 9 November 2018.
