FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Regulatory approval: On June 12, 2025, the FDA approved mitomycin intravesical solution (Zusduri; UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Approval was supported by the single-arm, multicenter ENVISION trial (NCT05243550), in which 78% of 223 evaluable patients achieved a complete response at 3 months; duration of response ranged from 0 to 25+ months, and 79% of responders remained in response for at least 12 months.

FDA approval (June 12, 2025)

The FDA approved mitomycin intravesical solution (Zusduri; UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Supporting evidence: ENVISION (NCT05243550)

Efficacy was evaluated in ENVISION, a single-arm, multicenter trial enrolling 240 adults with low-grade NMIBC recurring after prior TURBT and meeting 1–2 of: multiple tumors, solitary tumor >3 cm, and/or recurrence within 1 year. Patients received mitomycin 75 mg intravesically once weekly for 6 weeks. Tumor status was assessed every 3 months by cystoscopy, for-cause biopsy, and urine cytology.

Primary efficacy outcomes:

  • Complete response (CR) at 3 months (no detectable disease by cystoscopy and urine cytology; biopsy if warranted)
  • Duration of response (DOR)

Results (evaluable n=223):

  • CR rate: 78% (95% CI, 72–83)
  • DOR: 0 to 25+ months; 79% of responders remained in response for ≥12 months

Safety and dosing (selected)

Common adverse reactions (≥10%), including laboratory abnormalities: increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased AST/ALT, increased eosinophils, decreased lymphocytes, UTI, decreased neutrophils, hematuria. Serious adverse reactions occurred in 12% (including urinary retention 0.8%, urethral stenosis 0.4%). One fatal cardiac failure was reported.

Recommended dose: 75 mg (56 mL) intravesically once weekly for 6 weeks via urinary catheter.

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