On May 7, 2025 UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC (Press release, UroGen Pharma, MAY 7, 2025, View Source [SID1234652658]).
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The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions. The FDA carefully considers the advice of the Advisory Committee, but is not bound by its recommendations. The FDA has stated in its correspondence to the Company that they intend to complete their review in time to meet the Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025.
"We are excited to discuss our data with the Advisory Committee and broader medical community as we continue our mission to bring innovative solutions to patients suffering from bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "We believe UGN-102 represents a meaningful advancement for patients facing the recurrent and challenging nature of LG-IR-NMIBC, and we look forward to the opportunity to discuss its potential."
UGN-102 is in development as a therapeutic option for patients with recurrent LG-IR-NMIBC, a condition for which there are no FDA-approved drugs. The NDA is supported by results from the pivotal Phase 3 ENVISION trial which demonstrated a 79.6% complete response (CR) rate at 3 months after first instillation of UGN-102, and duration of response of 82.5% at 12 months after 3-month CR by Kaplan-Meier analysis.
About UGN-102
UGN-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 technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102, scheduled an ODAC meeting for May 21, 2025, and assigned a PDUFA target action date of June 13, 2025.
About Low-Grade Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S., bladder cancer is the second most common urologic cancer in men and primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. More specifically, LG-IR-NMIBC represents approximately 23,000 newly diagnosed bladder cancer patients each year and an estimated 59,000 recurrences annually among patients diagnosed in previous years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70% of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures.