Priority review for MSD’s Keytruda for Merkel cell carcinoma

This application is based on data from the Phase II KEYNOTE-017 trial, which showed an objective response rate of 56% at 14.9 months in patients taking the immunotherapy, including a 24% complete response rate and a 32% partial response rate.

"Merkel cell carcinoma, a rare type of skin cancer, is an aggressive and fast-growing disease that has been associated with mortality rates higher than other types of skin cancer, including melanoma," said Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

"KEYNOTE-017 represents the longest observation to date of patients with advanced Merkel cell carcinoma receiving anti-PD-1 therapy in the first-line setting, and demonstrated durable tumor control in these patients."

The FDA has set an action date of December 28 this year.

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