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UroGen Announces Outcome of Oncologic Drugs Advisory Committee for UGN-102 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company dedicated to developing and commercializing innovative
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n \n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. By a narrow margin, the ODAC voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent LG-IR-NMIBC.\n\n“While we are disappointed by today’s outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,” said Liz Barrett, President and CEO of UroGen. “The FDA carefully considers the independent advice from ODAC, and we look forward to working with the FDA as they complete their review of the application for UGN-102.”\n\nThe ODAC reviewed the body of clinical data supporting the efficacy and safety of UGN-102, including the results from the Phase 3 ENVISION study. “Low-grade intermediate-risk non-muscle invasive bladder cancer is a highly recurrent disease and often requires patients – many of whom are elderly – to undergo repeat surgeries under general anesthesia. This is a disease with high unmet needs, and we believe patients deserve more options,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “UroGen remains committed to developing innovative treatment options to people living with recurrent LG-IR-NIMBC.”\n\nThe most common treatment-emergent adverse events in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention, which are typically manageable in routine urologic practice. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN-102.\n\nThe NDA for UGN-102 is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of June 13, 2025.\n\nAbout UGN-102\n\nUGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technolo...