FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer

On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for patients with disease progression on or after platinum-containing chemotherapy. The Prescription Drug User Fee Act (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 Roger Dansey, MD, Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories. “The data with [pembrolizumab] 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 [pembrolizumab] to patients who may benefit as quickly as possible.”

The FDA previously granted Breakthrough Therapy designation to pembrolizumab for the second-line treatment of patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy.

KEYNOTE-052, KEYNOTE-045

The applications, which are seeking approval for 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 pembrolizumab 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 pembrolizumab 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, Merck announced that, although it did not show significant improvement in progression-free survival, the trial met its coprimary endpoint of overall survival and was stopped early at the recommendation of an independent Data Monitoring Committee.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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