UroGen submits FDA NDA for UGN-103 bladder cancer treatment
URGN•FDA filing for UGN-103
UroGen Pharma filed an FDA New Drug Application for UGN-103, an investigational intravesical mitomycin for recurrent LG-IR-NMIBC.
Phase 3 data supporting submission
The submission was backed by Phase 3 UTOPIA data showing a 77.8% complete response at three months and a 94.5% six-month duration of response.
