FDA Grants Priority Review to UGN-101 for Urothelial Cancer

December 19, 2019 – The FDA has granted a priority review designation to a new drug application (NDA) for UGN-101 (mitomycin gel) for the treatment of patients with low-grade, upper tract urothelial cancer (UTUC). The designation is based on results from the pivotal phase III OLYMPUS trial, in which a final analysis showed that UGN-101 elicited a complete response (CR) rate of 59% in this patient population. Under the Prescription Drug User Fee Act, the … (leggi tutto)