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In this video, part 1 in a 5-part series, panelists discuss how mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri) fits into the evolving management landscape for recurrent bladder tumors.
In this Special Report: RX Review from Urology Times, host Rahul Mehan, MD, is joined by Nick Liu, MD, for an expert-level discussion on the FDA approval of mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri) for low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).1,2
Liu and Mehan explore how this new intravesical therapy fits into the evolving management landscape for recurrent bladder tumors. With a clinical focus on minimally invasive urologic oncology, Liu shares his enthusiasm for incorporating mitomycin into practice, particularly in offering patients a nonsurgical, office-based option that avoids the burden and risks of repeat TURBT.
In the clip, Mehan and Liu break down key insights from the phase 3 ENVISION trial (NCT05243550), which supported the drug’s approval, and walk through practical patient selection. Liu outlines how multifocal disease, tumor size greater than 3 cm, and early recurrence within 1 year define intermediate risk—and why this group stands to benefit from more targeted and less invasive approaches.
Together, they address the real-world implications of shifting away from surgery-first models for recurrent low-grade disease. For busy private practices, the approval of an office-delivered chemoablative therapy may offer not just clinical value but operational flexibility—changing the conversation around bladder cancer recurrence and retreatment.
Part 2: RX Review: How mitomycin for intravesical solution works in treating LG-IR-NMIBC
Part 3: RX Review: A paradigm shift for low-grade, intermediate-risk NMIBC
Part 4: RX Review: TURBT vs chemoablation for low-grade, intermediate-risk NMIBC
Part 5: RX Review: Implementing mitomycin for LG-IR-NMIBC in clinical practice
Our Panelists:
Rahul Mehan, MD, is the founder of East Valley Urology Center in Mesa, Arizona.
Nick Liu, MD, is the medical director of urology at Valley Health System in Paramus, New Jersey.
Mehan and Liu report no relevant disclosures.
REFERENCES
1. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed June 12, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle
2. U.S. FDA approves UroGen’s ZUSDURI (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). News release. UroGen. Published online and accessed June 12, 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical
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