MSD receives priority review for Merkel cell carcinoma treatment
FDA are conducting a priority review of MSD’s Keytruda, a treatment for adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
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.”