Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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

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

The major efficacy outcomes were complete response (CR) at three months and duration of response (DOR). The 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 zero 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 one patient.

Full prescribing information for mitomycin intravesical solution will be posted on Drugs@FDA.

Based on a press release from the FDA.