FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings.
Merck, known as MSD outside the United States and Canada, 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.
Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are ineligible 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. The PDUFA, or target action, date for both applications is June 14, 2017.
“Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “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.”
The FDA previously 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.
The applications, which are seeking approval for Keytruda (pembrolizumab) monotherapy at a dose of 200 mg administered intravenously every three weeks, are based on data from the phase 2 KEYNOTE-052 trial and the phase 3 KEYNOTE-045 trial, respectively. KEYNOTE-052 is an open-label study investigating Keytruda as a first-line treatment in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing therapy.
KEYNOTE-045 is a randomized study investigating Keytruda as a second-line therapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with locally advanced or metastatic urothelial cancer that has recurred or progressed on or after platinum-containing chemotherapy. In October 2016, the company announced that, although it did not show significant improvement in progression-free survival, the trial met its co-primary endpoint of overall survival (OS) and was stopped early at the recommendation of an independent Data Monitoring Committee (DMC).
Keytruda is being evaluated in over 30 tumor types in more than 400 clinical trials, at least half of which combine Keytruda with other cancer treatments.
(Source: Business Wire)
Filed Under: Drug Discovery