Merck announced that the Food and Drug Administration (FDA) has accepted the new supplemental Biologics License Application (sBLA) under Priority Review for Keytruda (pembrolizumab) as a treatment for adults and children with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Merkel cell carcinoma is a rare form of skin cancer associated with higher mortality rates than other skin cancers. The sBLA included overall response rate (ORR) and duration of response (DOR) data from the Phase 2 KEYNOTE-017 trial; the findings were presented at the 2018 ASCO Annual Meeting.
“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,” stated Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.
Previously, the FDA granted Breakthrough Designation for Keytruda for this indication. A Prescription Drug User Fee Act (PDUFA) target date has been set for December 28, 2018.
Keytruda, an anti-PD-1 therapy, is already approved to treat various urological, colorectal, cervical, head and neck, hematologic, skin, and respiratory cancers. It is available as 50mg lyophilized powder for IV infusion and 25mg/mL solution for IV infusion in single-use vials.
For more information call (800) 672-6372 or visit Merck.com.