UroGen Pharma announces outcome of ODAC meeting for UGN-102

UroGen Pharma (URGN) announced the outcome of the meeting of the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration, which discussed the new drug application for investigational drug UGN-102 for intravesical solution. By a narrow margin, the ODAC voted 4 to 5 that the benefit/risk of UGN-102 for intravesical solution was favorable for the treatment of recurrent LG-IR-NMIBC. “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, CEO. “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.” The ODAC reviewed the body of clinical data supporting the efficacy and safety of UGN-102, including the results from the Phase 3 ENVISION study. The 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. The NDA for UGN-102 is currently under review by the FDA with a Prescription Drug User Fee Act date of June 13, 2025.