FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

“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 3 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 cisplatincontaining 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 and was stopped early at the recommendation of an independent Data Monitoring Committee.

Keytruda is being evaluated in over 30 tumour types in more than 400 clinical trials, at least half of which combine Keytruda with other cancer treatments.