The FDA has accepted for review two supplemental Biologics License Applications (sBLAs) for Keytruda (pembrolizumab), for treatment of patients with locally advanced or metastatic urothelial cancer.- Merck Inc.

Merck announced that the 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.

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 II KEYNOTE-052 trial and the phase III 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).