FDA approval of mitomycin hydrogel (Zusduri): a new non-surgical era for non-muscle-invasive bladder cancer (NMIBC)

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Abstract
Non-muscle-invasive bladder cancer (NMIBC) continues to present substantial management challenges, largely due to its high likelihood of recurrence and the routine need for repeated surgical procedures. Standard approaches, including transurethral resection of bladder tumor (TURBT) followed by intravesical therapies such as Bacillus Calmette Guerin or chemotherapy, are effective for many patients but are often limited by toxicity, procedural burden, and variable durability of response. In this context, the recent Food and Drug Administration approval of Zusduri, an intravesical mitomycin hydrogel, represents a noteworthy advancement for adults with recurrent low-grade, intermediate-risk NMIBC. This formulation is designed to transition into a gel within the bladder, extending the drug’s urothelial contact time and enabling in-clinic administration without anesthesia. Results from key clinical trials, i.e., OPTIMA II and ENVISION, reported meaningful chemoablative activity, achieving complete response rates, with a sizable proportion of responders remaining disease-free after 1 year. Most adverse events were manageable and localized, although isolated severe effects were documented. Despite this progress, questions regarding long-term recurrence patterns, broader accessibility, and cost remain unanswered and require future investigation. As real-world data accumulate, mitomycin may emerge as an important addition to the therapeutic landscape, offering a non-surgical option that could lessen dependence on repeated operative interventions and improve convenience for patients with NMIBC.

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