Posted by Michael Wonder on 06 Jul 2021
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in locally advanced cutaneous squamous cell carcinoma
6 July 2021 - Keytruda is now approved for the treatment of patients with recurrent or metastatic or locally advanced cSCC that is not curable by surgery or radiation.
Merck today announced that the U.S. FDA has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which Keytruda demonstrated an objective response rate of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.
