Sandip Prasad, MD, outlines 3 key takeaways from the ENVISION trial

Mitomycin for intravesical solution (Zusduri; formerly UGN-102) was approved by the FDA in June 2025 for the treatment of 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 (NCT05243550), which met its primary end point by demonstrating a 78% (95% CI, 72 to 83) complete rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

In a recent interview with Urology Times®, Sandip M. Prasad, MD, MPhil, outlined 3 key takeaways from the pivotal study. 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 emphasized several important aspects of this trial, starting with the reach and breadth of this treatment option. LG-IR-NMIBC is a common condition seen by urologists, he explained, meaning that mitomycin for intravesical solution can be used widely across urologic practice.

Secondly, Prasad noted the ease of administration of this therapy.

“You don't need to be an oncologist to do this type of treatment,” he said. “This is the same type of bladder treatment that you're comfortable doing with BCG, gemcitabine, [or] anything else that you give in the office.”

Lastly, Prasad touched on the evolving treatment landscape in NMIBC, emphasizing that shift away from surgery in these patients.

“We're flipping the switch on the way in which we should probably treat these bladder cancers going forward,” he concluded.

Prasad reports relevant disclosures with UroGen Pharma, Inc.

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 29, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle