Zusduri is the first FDA-approved targeted, non-surgical treatment for recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer. It delivers mitomycin C directly into the bladder using RTGel® technology, which turns from liquid to gel at body temperature. This allows the drug to stay in contact with the bladder wall for hours, maximizing local effect while minimizing systemic toxicity.
In the Phase 3 ENVISION trial, 78% of patients achieved a complete response at three months, with over 70% maintaining tumor-free status at two years. This offers a major alternative to repeated surgeries like transurethral resection of bladder tumor, reducing both physical and psychological burden.
Zusduri is given weekly for six weeks via bladder instillation. Side effects are usually mild and urinary-related, including pain, infection, and blood in urine. It is contraindicated in patients with bladder perforation or hypersensitivity to mitomycin.