FDA grants priority review to UGN 101 for upper tract urothelial cancer.- UroGen Pharma

UroGen Pharma announced the FDA accepted for filing and granted priority review for its New Drug Application (NDA) for UGN 101 (mitomycin gel) for instillation as a potential treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). If approved, UGN-101 would be the first non-surgical treatment option for LG UTUC.

The NDA is supported by the positive results from the pivotal Phase III OLYMPUS clinical trial. Results from a final analysis of the primary endpoint showed that UGN 101 demonstrated a complete response rate of 59 percent in patients with LG UTUC. In addition, the durability of response was estimated as 89 percent at six months and 84 percent at 12 months by Kaplan Meier analysis. Median time to recurrence was estimated to be 13 months. The most commonly reported treatment emergent adverse events were ureteric stenosis (43.7%), urinary tract infection (32.4%), haematuria (31.0%), flank pain (29.6%) nausea (23.9%), dysuria (21.1%), renal impairment (19.7%) and vomiting (19.7%). The majority of these adverse events were mild to moderate, with 8.5% of patients having events of ureteric stenosis reported as severe.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020. The company is on track for the potential launch of UGN-101 by mid-year 2020. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN 101 for the treatment of LG UTUC.