Summary of the scope and indications of mitomycin intravesical solution (Zusduri) for the treatment of bladder cancer

Mitomycin intravesical solution (Zusduri) is a drug designed to treat non-muscle invasive bladder cancer (NMIBC), especially in low-grade, recurrent, intermediate-risk patient groups. Although the tumors in these patients have not invaded the bladder muscle layer, they have a tendency to recur repeatedly. Traditionally, they need to undergo multiple transurethral resections of bladder tumors (TURBT), which has limited efficacy and a high recurrence rate. The launch of Zusduri provides these patients with a new option for non-surgical, local treatment.

Zusduri's core target audience is patients who are not suitable for cystectomy or repeated TURBT surgery due to age, physical condition or other diseases. It is administered through bladder instillation once a week for 6 consecutive weeks to reduce the impact on the whole body and is especially suitable for people at high risk of surgery. Research shows that its complete remission rate is as high as 78%, and it has good ability to maintain remission and significantly delay the time of recurrence.

Zusduri uses UroGen's unique RTGel® thermosensitive gel platform, which allows the drug to form a gel-like state in the bladder, extending the contact time between the drug and cancerous tissue and improving local drug efficacy. This mechanism not only enhances the anti-cancer effect of mitomycin, but also reduces the treatment blind area caused by rapid drug discharge and improves the ability to control recurrent tumors, especially in patients with repeated perfusion failures.
It should be noted that Zusduri is currently only suitable for low-grade, intermediate-risk tumors that do not involve the bladder muscle layer, and is not currently suitable for high-grade, muscle-invasive (MIBC) or metastatic bladder cancer cases. For such advanced patients, systemic chemotherapy, radiotherapy or total cystectomy are still the main treatment strategies. Therefore, the use of Zusduri should be strictly screened and evaluated by professional urologists based on tumor stage and patient status.
Reference: https://www.fda.gov/drugs/