Posted by Michael Wonder on 18 Dec 2018
UroGen Pharma initiates rolling submission of new drug application for UGN-101 for the treatment of low-grade upper tract urothelial cancer
17 December 2018 - Company expects to complete submission by mid-2019, with potential approval in 2019.
UroGen Pharma today announced that it has initiated the rolling submission with the U.S. FDA of the new drug application for UGN-101 (mitomycin gel) for instillation as a treatment for patients with low-grade upper tract urothelial cancer (LG UTUC).
The submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC.
The FDA previously granted orphan drug, fast track, and breakthrough therapy designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
