The FDA has accepted a new drug application for UGN-103 (mitomycin), a novel intravesical therapy for adults with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (NMIBC). Backed by phase 3 UTOPIA trial data showing a 77.8% complete response rate at 3 months, the agency set a target action date of June 14, 2027. This follows the FDA's June 2025 approval of the related therapy UGN-102 for the same indication.
The FDA has accepted a new drug application (NDA) for UGN-103 (mitomycin) intravesical solution, developed by UroGen Pharma, for the treatment of adults with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (NMIBC). The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.
UGN-103 uses UroGen's proprietary RTGel technology — a thermally responsive hydrogel that is liquid when chilled for easy administration, then converts to a semisolid gel depot inside the bladder to sustain local drug exposure. The NDA is supported by the phase 3 UTOPIA trial, which enrolled 99 patients who received UGN-103 at 75 mg once weekly for 6 weeks.
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Why it matters: With UGN-102 already approved for the same indication in June 2025, UGN-103 represents a next-generation refinement with a simplified manufacturing and reconstitution process — potentially expanding treatment options for the many bladder cancer patients who face recurrence.
