Mitomycin intravesical solution (Zusduri; UroGen Pharma) may now be used to treat adult patients with recurrent intermediate-risk, low-grade, non-muscle invasive bladder cancer (LG-NMIBC) after an FDA approval in June.1
A group of researchers evaluated the treatment’s efficacy in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with LG-NMIBC that recurred after prior transurethral resection of bladder tumor and met 1 or 2 of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within 1 year. Trial participants received 75 mg of mitomycin intravesical solution instilled once a week for 6 consecutive weeks. Assessment of tumor status was performed every 3 months by cystoscopy, for-cause biopsy, and urine cytology.
Among the 223 patients evaluable for response, 78% (95% confidence interval, 72-83) had a complete response. The duration of response ranged from 0 to 25+ months, and 79% of responding patients remained in response for at least 12 months.
The most commonly reported adverse reactions 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 adverse reactions occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in 1 patient.
Reference
- FDA. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer [press release]. June 12, 2025. Accessed July 1, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle