The FDA has approved mitomycin intravesical solution (brand name Zusduri, also known as UGN-102) as a new treatment option for adults with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC).
What This Means for Patients
- First FDA-Approved Medicine: This is the first time the FDA has approved a nonsurgical medicine for this specific group of bladder cancer patients.
- Alternative to Surgery: Until now, the standard treatment was repeated surgeries (transurethral resection of bladder tumors, or TURBT), which can be burdensome for patients. Mitomycin intravesical solution offers a minimally invasive alternative that is given directly into the bladder using a catheter in an outpatient setting.
How the Treatment Works
- Administration: The treatment involves six weekly instillations (once per week for six weeks) of mitomycin solution into the bladder via a urinary catheter.
- Who Is Eligible: Adult patients with recurrent, low-grade, intermediate-risk NMIBC. This includes those with multiple tumors, a single tumor at least 3 cm in size, or frequent recurrences within a year.
Results from the ENVISION Clinical Trial
- Complete Response Rate: In the phase 3 ENVISION trial, 78% of patients had no detectable cancer at three months after starting treatment.
- Durability: Of those who responded, 79% remained cancer-free for at least 12 months3.
- Longer-Term Data: At 18 months, about 81% of patients who initially responded remained cancer-free3.
- Side Effects: The most common side effects included pain or burning during urination, blood in the urine, urinary tract infections, frequent urination, fatigue, and urinary retention. Serious side effects occurred in 12% of patients, and one patient died from heart failure during the study35.
The treatment is expected to be available in the United States starting around July 1, 2025. The ENVISION trial continues to monitor long-term safety and effectiveness. The approval followed a close review by the FDA, including input from an advisory committee, which debated the need for further randomized trials in this patient group.
Mitomycin intravesical solution (Zusduri) is now FDA-approved as the first nonsurgical chemoablation treatment for adults with recurrent, low-grade, intermediate-risk NMIBC, offering hope for fewer surgeries and a new standard of care.
Reference
Prasad SM, Mihaylov NV, Khuskivadze A, et al. Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. J Clin Oncol. 2025;43(suppl 16):4598.
