Sandip Prasad, MD, on the approval of mitomycin intravesical solution for LG-IR-NMIBC

Mitomycin for intravesical solution (Zusduri; formerly UGN-102) was granted FDA approval in June 2025 for patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).¹ The approval was supported by data from the phase 3 ENVISION trial, which met its primary end point by demonstrating a 78% complete response rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

In an interview with Urology Times®, Sandip M. Prasad, MD, MPhil, principal investigator on the ENVISION trial, shares his thoughts on the impact of this approval for the field. As the first FDA-approved medication in this setting, Prasad alludes to the practice-changing nature of this agent.

“The hallmark of this disease is recurrence, and unfortunately, the only treatment historically was surgery,” he explained. “Having a non-surgical option [such as] Zusduri, the topical mitomycin agent [that] was recently approved, gives urologist a completely different and very novel way of addressing intermediate-risk, recurrent non–muscle invasive bladder cancer.”

Prasad is the vice chair of urology and surgical director of general uro-oncology at Atlantic Health System, Morristown Medical Center, as well as a partner at Garden State Urology in New Jersey.

Prasad also touched on the importance of non-surgical options particularly for patients with LG-IR-NMIBC, of whom many are older and have risk factors that make surgery an inadequate option.

He explained, “Over time, we've recognized that these TURBTs carry some degree of risk with them every time we take a patient to the operating room, and on average, the majority of these patients will have multiple trips to the operating room after their diagnosis. So, again, I think having a novel treatment is really important for urologists.”

Drawing on his own clinical experience, Prasad also emphasized that patients are seeking out this treatment option on their own.

“I can't think of many agents that I've studied on a clinical trial where I've had patients ask me almost every time I've seen them, ‘What's the update on that trial? Is that drug approved yet or not?’ And for the first time, about a month ago, we've been able to tell patients, ‘Yeah, we actually have that drug now.’ I’ve put several patients on the drug now already since approval.”

REFERENCE

1. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. June 12, 2025. Accessed August 12, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle