U.S. FDA Approves UroGen’s ZUSDURI™ as First Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Friday, June 13, 2025
UroGen Pharma Ltd., a biopharmaceutical company focused on treatments for urothelial and rare cancers, has received approval from the U.S. Food and Drug Administration (FDA) for ZUSDURI™ (mitomycin) for intravesical use. It is now the first and only FDA-approved therapy for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
ZUSDURI combines mitomycin with a sterile hydrogel using UroGen’s proprietary RTGel® sustained-release technology. This formulation has been designed to improve tumour ablation. The FDA's decision was based on results from the Phase 3 ENVISION trial, which showed a 78% complete response rate at three months. Of those who responded, 79% remained free of recurrence one year later.
Until now, the standard treatment for LG-IR-NMIBC has involved a surgical procedure known as transurethral resection of bladder tumour (TURBT), often performed under general anaesthesia. Due to the condition’s tendency to return, repeated surgeries are commonly required.
ZUSDURI offers a non-surgical alternative for adults with recurrent disease, potentially reducing the need for repeated TURBT procedures.
The most commonly reported adverse reactions (≥10%) in clinical studies included increased creatinine and potassium levels, painful urination, reduced haemoglobin, elevated liver enzymes, increased eosinophils, reduced lymphocytes, urinary tract infections, reduced neutrophils, and blood in the urine. Serious side effects were observed in 12% of patients, with urinary retention and urethral narrowing among the more serious but less frequent events.
Source: urogen.com
