On June 12, 2025, the U.S. Food and Drug Administration (FDA) approved mitomycin intravesical solution (Zusduri) for adult patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer.
Mitomycin intravesical solution is a reverse thermal hydrogel formulation of mitomycin that is administered intravesically via a urethral catheter in an outpatient setting. The reverse thermal properties of the formulation allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semisolid gel depot following instillation into the bladder.
Study Details
Efficacy was evaluated in ENVISION, a single-arm, multicenter phase III trial in 240 adults with low-grade non–muscle-invasive bladder cancer that recurred after prior transurethral resection of bladder tumor and met one to two of the following criteria: multiple tumors, a solitary tumor > 3 cm, and/or recurrence within 1 year. Patients received mitomycin intravesical solution at 75 mg 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.
The major efficacy outcomes were complete response at 3 months and duration of response. Complete response was defined as no detectable disease in the bladder by cystoscopy and urine cytology. If warranted, a biopsy was performed. Among the 223 patients evaluable for response, 78% (95% confidence interval [CI] = 72%–83%) had a complete response. The duration of response ranged from 0 to more than 25 months and 79% of responding patients remained in response for at least 12 months.
Safety
The most common adverse reactions (≥ 10%), including laboratory 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, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in one patient.
The recommended mitomycin dose is 75 mg (56 mL) instilled once weekly for 6 weeks into the bladder via a urinary catheter.
