February 3, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. In particular, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are not eligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy.
Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said: “Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer. The data with KEYTRUDA administered to patients with advanced urothelial cancer are promising, and we look forward to working with the FDA throughout the review process with the goal of bringing KEYTRUDA to patients who may benefit as quickly as possible.”
Previously, the FDA granted Breakthrough Therapy Designation to KEYTRUDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy.