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Zusduri is a sustained-release, hydrogel-based formulation of mitomycin designed for intravesical (bladder) administration. It is indicated for the treatment of adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), particularly in patients whose disease has recurred after prior surgical removal. The drug utilizes UroGen’s proprietary RTGel technology to prolong exposure of bladder tissue to mitomycin, enabling local tumor ablation by non-surgical means. Mitomycin acts as an alkylating agent that inhibits DNA synthesis and crosslinks DNA strands, thereby preventing cancer cell growth and division. FDA approval was based on the Phase 3 ENVISION trial showing a 78% complete response rate at three months and durable responses in most patients at one year[1][4][6][8].
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