UroGen Pharma, a biotech company focused on developing treatments for urothelial and specialty cancers, has received U.S. FDA approval for ZUSDURI (mitomycin) for Intravesical Solution. ZUSDURI is the first approved medicinal treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC). It combines mitomycin with UroGen’s proprietary sustained-release RTGel hydrogel, designed for targeted tumour removal.

The approval is based on results from the Phase 3 ENVISION trial, where ZUSDURI achieved a 78% complete response at 3 months, with 79% of those patients remaining event-free after 12 months. Currently, LG-IR-NMIBC is typically treated with transurethral resection of bladder tumour (TURBT), a surgical procedure often requiring general anaesthesia and possible repeat surgeries due to high recurrence rates. ZUSDURI is expected to be available in the U.S. starting in July.