Keytruda sBLA Granted Priority Review for Advanced Hepatocellular Carcinoma

The FDA has set a PDUFA action date of November 9, 2018
The FDA has set a PDUFA action date of November 9, 2018

A new supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda; Merck) as a treatment for advanced hepatocellular carcinoma (HCC), has been accepted and granted priority review by the Food and Drug Administration (FDA). 

The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment. Participants received pembrolizumab 200mg every 3 weeks for 2 years or until disease progression. Results showed that 18 of the 104 patients had an objective response (17%; 95% CI 11-26), which was the primary endpoint.

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The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 9, 2018. "The data supporting our application provide a clear rationale for the advancement of the Keytruda clinical program for hepatocellular carcinoma," said Dr Scot Ebbinghaus, VP of clinical research at Merck Research Laboratories. 

The Company is currently conducting 2 separate pivotal Phase 3 trials (KEYNOTE-240 and KEYNOTE-394) evaluating Keytruda as monotherapy in second-line HCC and also in combination with other treatments, including lenvatinib

Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is approved for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.

For more information visit Merck.com.