Intravesical Mitomycin Approved for Low-Grade Non-Muscle Invasive Bladder Cancer
On June 12, 2025, the US Food and Drug Administration (FDA) approved mitomycin intravesical solution for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC). This approval was based on results from the ENVISION trial.
The single-arm, multicenter ENVISION trial enrolled 240 patients with low-grade NMIBC who had recurred following transurethral resection of bladder tumor (TURBT) and met 1 to 2 of the following criteria: multiple tumors, solitary tumor that is larger than 3 cm, and/or recurrence within 1 year. These patients received 75 mg mitomycin intravesical solution, instilled once weekly for 6 consecutive weeks. Every 3 months tumor status was assessed via cystoscopy, for-cause biopsy, and urine cytology. The major efficacy outcomes were complete response (defined as no detectable disease in bladder by cystoscopy and urine cytology) at 3 months and duration of response.
Of 223 evaluable patients, 78% had a complete response. The duration of response ranged from 0 to 25+ months, with 79% of patients who responded remaining in response for at least 12 months. The most common adverse events occurring in > 10% of patients and including lab abnormalities, were 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 and included urinary retention and urethral stenosis. There was 1 patient who had a fatal reaction of cardiac failure.
The recommended dose of mitomycin is 75 mg instilled once weekly for 6 weeks into the bladder via a urinary catheter.
Source:
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. 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
