Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking accelerated approval for KEYTRUDA, Merck’s anti-PD-1 therapy, 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 2 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.
“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. We look forward to working closely with the FDA throughout the review process and to bringing KEYTRUDA to patients with Merkel cell carcinoma.”
Merck’s long-term commitment to skin cancers includes a broad clinical development program studying KEYTRUDA as monotherapy and in combination with other novel mechanisms. The program, which is comprised of over 4,500 patients across more than 10 Merck-sponsored clinical studies, is evaluating KEYTRUDA across most settings and stages, as well as different subtypes of the disease.