UroGen Pharma Ltd.'s experimental medicine to treat a rare type of bladder cancer has been accepted for priority review by the U.S. Food and Drug Administration.
The medicine, UGN-101, also known as mitomycin gel, is intended for low-grade upper tract urothelial cancer. The drug candidate will receive a decision on approval from the FDA by April 18, 2020, New York-based UroGen said in its Dec. 19 press release.
During clinical trials, UGN-101 was able to reduce or eliminate patients' cancer for about 13 months.
If approved, UGN-101, which has also received orphan-drug, fast-track and breakthrough-therapy designations, will be the first nonsurgical treatment for low-grade upper tract urothelial cancer, according to UroGen.