Sesen Bio Inc. has initiated the submission of bladder cancer drug Vicinum to the U.S. Food and Drug Administration for approval.
The Cambridge, Mass.-based company expects to complete the rolling submissions process by 2020. Sesen plans to request a priority review if the FDA accepts the application.
Vicinum, which treats high-grade, non-muscle-invasive bladder cancer, was granted fast-track designation from the U.S. regulator in 2018. The drug removed detectable cancer in 39% to 80% of patients in a late-stage clinical trial, according to results issued in May 2018.