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In this video, part 3 in a 5-part series, panelists discuss the long-term clinical impact and health care system implications of mitomycin for intravesical solution (Zusduri; formerly UGN-102).
In this Special Report: RX Review from Urology Times, host Rahul Mehan, MD, and Nick Liu, MD, discuss the long-term clinical impact and health care system implications of mitomycin for intravesical solution (Zusduri; formerly UGN-102) for the treatment of recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). The treatment was approved by the FDA on June 12, 2025.1,2
Building on earlier discussion of the phase 3 ENVISION trial (NCT05243550), Liu introduces data from the ATLAS study (NCT04688931)—a randomized phase 3 trial comparing UGN-102 (with or without transurethral resection of bladder tumor [TURBT]) to TURBT alone. Although initial complete response rates at 3 months were similar between the 2 groups (approximately 65%), the 12-month disease-free survival told a different story: 72% of patients treated with UGN-102 remained recurrence-free, compared with just 50% in the TURBT-only group. These findings, Liu says, reinforce the idea that surgery may no longer be necessary for many patients with recurrent low-grade disease.
Mehan highlights how this shift could ease pressure on an already overwhelmed urology workforce. With most urologists managing a growing volume of bladder cancer surveillance and repeat procedures, mitomycin for intravesical solution introduces a new, office-based treatment option that could dramatically improve efficiency—reducing the OR burden, minimizing anesthesia exposure, and freeing up time to serve more patients.
Together, they emphasize that beyond being clinically effective, mitomycin for intravesical solution represents a paradigm shift in how—and where—urologists manage a highly recurrent disease. The next challenge? Ensuring payer coverage and access to make widespread adoption feasible in both community and academic settings.
Part 1: RX Review: Redefining treatment for LG-IR-NMIBC
Part 2: RX Review: How mitomycin for intravesical solution works in treating LG-IR-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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