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Sesen Bio begins US FDA application process for bladder cancer drug

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Sesen Bio begins US FDA application process for bladder cancer drug

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.