On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Full prescribing information for Zusduri will be posted on Drugs@FDA.
Efficacy was evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor (TURBT) and met 1-2 of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within 1 year. Patients received 75 mg 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.
The major efficacy outcomes were complete response (CR) at 3 months and duration of response (DOR). CR 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% CI: 72, 83) had a CR. The DOR ranged from 0 to 25+ months and 79% of responding patients remained in response for at least 12 months.
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 1 patient.
The recommended mitomycin dose is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
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