Posted by Michael Wonder on 10 Nov 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
10 November 2018 - Approval marks 14th indication for Keytruda.
Merck today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The approval was based on data from KEYNOTE-224, a single-arm, open-label, multi-center trial evaluating Keytruda in 104 patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib.
