India, June 12 -- UroGen Pharma Ltd. (URGN) announced that the U.S. Food and Drug Administration has approved ZUSDURI (mitomycin) for Intravesical Solution as the first and only medication indicated for the treatment of recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer or LG-IR-NMIBC.
The approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response (CR) for patients at 3 months, and of those patients 79% remained event-free 12 months later.
ZUSDURI is expected to be available in the U.S. on or around July 1, 2025, for the treatment of adults with recurrent LG-IR-NMIBC.
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