Mitomycin intravesical solution is approved by the USFDA for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adults with recurring low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The efficacy was assessed in ENVISION (NCT05243550), a single-arm, multicenter trial involving 240 adults with low-grade NMIBC that recurred following previous transurethral resection of bladder tumor (TURBT) and satisfied 1-2 of the subsequent criteria: multiple tumors, a solitary tumor exceeding 3 cm, and recurrence within one year. Patients were administered 75 mg of mitomycin as an intravesical solution once weekly for a duration of 6 consecutive weeks. Evaluation of tumor status was conducted every three months using cystoscopy, targeted biopsy, and urine cytology.

The primary efficacy outcomes were complete response (CR) at three months and duration of response (DOR). Complete remission (CR) was defined as the absence of detectable disease in the bladder as determined by cystoscopy and urine cytology. If necessary, we conducted a biopsy. Of the 223 patients assessed for response, 78% (95% CI: 72, 83) achieved a complete response (CR). The duration of response (DOR) varied from 0 to over 25 months, with 79% of patients who responded maintaining their response for a minimum of 12 months.

The common side effects (occurring in 10% or more of patients) included high creatinine levels, high potassium levels, painful urination, low hemoglobin, high aspartate aminotransferase, high alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infections, low neutrophils, and blood in urine. 12% of individuals experienced severe adverse responses, including urine retention (0.8%) and urethral stenosis (0.4%). One patient experienced a fatal adverse event resulting in heart failure.

The advised dosage of mitomycin is 75 mg (56 mL), administered weekly for six weeks into the bladder with a urinary catheter.