FDA Alert

FDA Approves Mitomycin Intravesical Solution for Recurrent Non-Muscle Invasive Bladder Cancer

Miranda Manier, BA

Key Highlights

  • The FDA approved mitomycin intravesical solution on June 12, 2025, for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
  • In the ENVISION trial, 78% of 223 evaluable patients achieved a complete response at 3 months, and 79% of responders remained in response for at least 12 months.
  • Patients received 75 mg of mitomycin intravesical solution instilled into the bladder once weekly for 6 weeks.
  • Common adverse reactions (≥10%) included dysuria, hematuria, urinary tract infection, and various laboratory abnormalities; one fatal cardiac failure occurred.

On June 12, 2025, the FDA approved mitomycin intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Efficacy was evaluated in the ENVISION trial (NCT05243550), a single-arm, multicenter study of 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor (TURBT) and met one to two of the following criteria: multiple tumors, a solitary tumor larger than 3 cm, and/or recurrence within 1 year. Patients received 75 mg of mitomycin intravesical solution instilled once weekly for 6 consecutive weeks. Tumor status was assessed every 3 months by cystoscopy, for-cause biopsy, and urine cytology.

Among 223 patients evaluable for response, 78% (95% CI: 72, 83) achieved a complete response (CR) at 3 months. Duration of response (DOR) ranged from 0 to more than 25 months. Of those who responded, 79% 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 and included urinary retention (0.8%) and urethral stenosis (0.4%). One patient experienced a fatal adverse reaction of cardiac failure.

The recommended dose of mitomycin intravesical solution is 75 mg (56 mL), instilled into the bladder once weekly for 6 weeks via a urinary catheter.

Healthcare professionals should report serious adverse events to the FDA’s MedWatch Reporting System.

Reference
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. June 12, 2025. Accessed June 13, 2025: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle