UroGen Pharma has announced a groundbreaking achievement with the FDA approval of ZUSDURI, making it the first and only FDA-approved medication specifically designed for adults facing recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This form of bladder cancer is characterized by high recurrence rates, often necessitating repeated surgical procedures known as transurethral resections of bladder tumor (TURBT) under general anesthesia – a significant burden for patients.

ZUSDURI offers a novel, non-surgical alternative by combining the chemotherapy agent mitomycin with UroGen's proprietary RTGel® technology, which enables sustained release of the drug directly to the tumor site for potent ablation. This innovative approach is supported by compelling data from the pivotal Phase 3 ENVISION trial, where ZUSDURI achieved an impressive 78% complete response rate at three months. Crucially, of those responders, 79% remained event-free for 12 months thereafter, highlighting its durable efficacy. This landmark approval signifies a major leap forward for the estimated 59,000 U.S. patients annually who can now potentially avoid multiple invasive surgeries, dramatically improving their quality of life and redefining the treatment landscape in uro-oncology.