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UroGen Pharma starts rolling US FDA submission for bladder cancer drug

Israel's UroGen Pharma Ltd. started the rolling submission of a new drug application to the U.S. Food and Drug Administration for cancer therapy UGN-101.

UGN-101, also known as mitomycin gel, is intended to treat low-grade upper tract urothelial cancer, a type of bladder cancer.

The drug's application is supported by data from a late-stage trial, called Olympus, topline results of which is expected in January 2019. The company anticipates to complete the rolling submission by mid-2019, and to receive approval within the same year.

UroGen Pharma said UGN-101 would provide a nonsurgical treatment option for urothelial cancer, potentially eliminating the need for repetitive surgical intervention and kidney removal.

The FDA has granted UGN-101 orphan-drug, fast-track and breakthrough-therapy designations.