FDA Grants Priority Review to sBLA for Pembrolizumab in Advanced Hepatocellular Carcinoma

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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