Mitomycin Intravesical Solution Approved for Low-Grade Non–Muscle Invasive Bladder Cancer
Expert Perspectives · Lyn Brook · 2025-06-16
The FDA has granted approval to mitomycin intravesical solution (Zusduri™, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).
Why This Approval Matters
The approval of mitomycin intravesical solution provides a new non-surgical treatment option for patients with LG-IR-NMIBC who have experienced recurrence following transurethral resection of bladder tumor (TURBT), offering a valuable alternative to repeated TURBT procedures for patients with recurrent disease.
Breaking Down the ENVISION Trial
Mitomycin intravesical solution was approved based on results from the ENVISION trial (NCT05243550), a single-arm, multicenter trial involving 240 adults with low-grade NMIBC that recurred after prior TURBT. Patients also met one to two of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within one year. Patients were administered 75 mg of mitomycin intravesical solution instilled once a week for six consecutive weeks. Tumor status was assessed every three months by cystoscopy, for-cause biopsy, and urine cytology.
Key efficacy end points included complete response (CR) at three 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.
Mitomycin intravesical solution produced the following results:
- Among the 223 patients, 78% had a CR.
- The DOR ranged from 0 to 25+ months, and 79% of responding patients remained in response for at least 12 months.
Managing Adverse Events
The most common adverse events experienced by ≥10% of patients, 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 and urethral stenosis. A fatal adverse reaction of cardiac failure occurred in one patient.
Clinical Implications and Future Outlook
The benefit-risk profile was favorable, supporting UGN-102 as a nonsurgical alternative for transurethral resection of bladder tumors in this patient population,” concluded Sandip M. Prasad, MD, a Physician at Morristown Medical Center in Atlantic Health System and Garden State Urology, and colleagues, in their published results of the ENVISION trial.
Dosing and Administration
The recommended mitomycin dose is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter.