PEMBROLIZUMAB APPROVAL FOR HCC

The U.S. Food and Drug Administration (FDA) recently accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as a second-line treatment for patients with advanced hepatocellular carcinoma.

This sBLA, which is seeking accelerated approval for this new indication, is based on data from the phase II KEYNOTE-224 trial, which was recently presented at the 2018 ASCO Annual Meeting and published simultaneously in The Lancet Oncology. 

The FDA has set a Prescription Drug User Fee Act, or target action, date of November 9, 2018.