FDA

Zusduri approved for recurrent low-grade bladder cancer

June 18, 2025

Brand name: Zusduri

Generic name: mitomycin intravesical solution

Manufacturer: UroGen Pharma

Approval date: June 12, 2025

FDA approved Zusduri (mitomycin intravesical solution) for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC).

Efficacy

Efficacy was evaluated in the single-arm, multicenter ENVISION trial (NCT05243550) involving 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor 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% confidence interval, 72-83) had a CR. The DOR ranged from 0 to 25+ months and 79% of responding patients remained in response for ≥12 months.

Safety

The most common (≥10%) adverse reactions reported with mitomycin intravesical solution were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased AST, increased ALT, increased eosinophils, decreased lymphocytes, UTI, decreased neutrophils, and hematuria. Serious adverse reactions occurred in 12% of patients who received Zusduri, including urinary retention and urethral stenosis.

Recommended dose

The recommended dosage of Zusduri is 75 mg (56 mL) instilled once weekly for 6 weeks.

Sources:

FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

Zusduri (mitomycin intravesical solution) [package insert] Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215793s000lbl.pdf Revised June 2025. Accessed June 17, 2025.

US FDA approves UroGen’s Zusduri™ (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). {News release]. 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical