The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.