Recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) has traditionally required repeated TURBT surgeries due to high recurrence rates, placing significant physical and emotional burdens on patients. Elderly patients, in particular, face frequent procedures under anesthesia and ongoing surveillance, which can severely impact quality of life.
FDA-approved Zusduri (mitomycin intravesical solution) now provides the first non-surgical treatment alternative. Using RTGel® technology, a reverse-thermal hydrogel that gels at body temperature, Zusduri prolongs bladder contact with chemotherapy from minutes to six hours, enhancing tumor penetration and reducing recurrence risk.
Approval was based on the ENVISION trial, which demonstrated a 78% complete response at three months and 79% of responders remaining disease-free for 12 months or more. Well-tolerated with standard intravesical therapy side effects, Zusduri shifts LG-IR-NMIBC management from repeated surgeries to an office-based, patient-friendly approach, offering durable responses and improving patient quality of life.