Sandip Prasad, MD, on the safety profile for mitomycin for intravesical solution

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, discussed the safety profile for mitomycin for intravesical solution based on data from the pivotal trial. 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.

Overall, the most common adverse events (AEs) reported in the trial included increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. Serious AEs were reported in 12% of patients. These included 2 treatment-related serious AEs of urinary retention (0.8%) and urethral stenosis (0.4%).

“Mitomycin has a multi-decade history of experience with urologists, so we're not really giving something novel that we're not familiar with,” Prasad concluded. “Systemic side effects like we worry about sometimes with our systemic immunotherapy agents [are] not really a concern with these types of topical chemoablation agents. So overall, [these were] very safe side effects, well within the wheelhouse of what urologists are able to manage.”

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 26, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle