UroGen Pharma Files FDA Application for UGN-103, Citing 77.8% Response Rate

UroGen Pharma submitted a New Drug Application (NDA) to the FDA for its investigational drug, UGN-103. This mitomycin-based formulation treats adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Data from the Phase 3 UTOPIA clinical trial supports the submission. The trial demonstrated a 77.8% three-month complete response rate.

UGN-103 features a streamlined manufacturing and reconstitution process compared to existing treatments.