trending Market Intelligence /marketintelligence/en/news-insights/trending/N93WWTIfoL7TuxoZIlc5LA2 content esgSubNav
In This List

UroGen Pharma starts rolling US FDA submission for bladder cancer drug

Blog

Gauging Supply Chain Risk In Volatile Times

Blog

Insight Weekly: Banks' efficiency push; vacuuming carbon; Big Pharma diversity goals

Blog

The Future of Risk Management Digitization in Credit Risk Management

Blog

Climate Credit Analytics: Diving into the model


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.