FDA grants accelerated approval for Keytruda to treat Merkel call carcinoma. Merck Inc.

Merck Inc., announced that the FDA has approved Keytruda, Merck�s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the results of the Cancer Immunotherapy Trials Network (CITN)�s CITN-09/KEYNOTE-017 trial.

In this Phase II trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, Keytruda monotherapy demonstrated an objective response rate of 56 percent (95% CI, 41-70), with a complete response rate of 24 percent (95% CI, 13-38) and a partial response rate of 32 percent (95% CI, 20-47).

This indication is approved under accelerated approval based on tumor 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