Posted by Michael Wonder on 20 Dec 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, a rare form of skin cancer
19 December 2018 - Accelerated approval based on results of CITN-09/KEYNOTE-017, where Keytruda monotherapy demonstrated an objective response rate of 56%.
Merck today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and paediatric 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 2 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% (95% CI, 41-70), with a complete response rate of 24% (95% CI, 13-38) and a partial response rate of 32% (95% CI, 20-47). 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.
