Keytruda filed with FDA and granted priority review for Merkel cell carcinoma.- Merck Inc.

Merck Inc announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking accelerated approval for Keytruda (pembrolizumab), for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This sBLA is based on data from the Phase II KEYNOTE-017 trial including overall response rate (ORR) and duration of response (DOR); these data were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. In July 2017, Keytruda was granted Breakthrough Therapy Designation by the FDA for this indication. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Dec. 28, 2018.

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. 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.