UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Core Insights - UroGen Pharma announced a 24-month Duration of Response (DOR) of 72.2% for ZUSDURI in patients who achieved a complete response at three months from the Phase 3 ENVISION trial, indicating sustained efficacy for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2][3] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, with ZUSDURI being a significant product for treating recurrent LG-IR-NMIBC [7] - The company utilizes proprietary RTGel technology, which allows for sustained release of medication directly into the bladder, providing a non-surgical treatment option [4][7] Product Details - ZUSDURI (mitomycin) is an FDA-approved intravesical solution for adults with recurrent LG-IR-NMIBC, marking a transformative step in managing this chronic cancer [2][3][8] - The treatment is administered in an outpatient setting, which can improve patient quality of life compared to traditional surgical options [2][4] Clinical Trial Insights - The Phase 3 ENVISION trial involved 240 patients and evaluated the efficacy and safety of ZUSDURI, with a primary endpoint of complete response rate at three months [6] - The trial demonstrated that the event rate remained stable over time for patients who achieved a complete response, reinforcing the therapy's potential as a durable treatment option [2][3] Market Context - LG-IR-NMIBC affects approximately 82,000 individuals annually in the U.S., with around 59,000 experiencing recurrence, highlighting the need for effective treatment options [5] - The existing standard of care involves repeated surgical procedures, which can negatively impact patients' health and quality of life [2][5]