Victory in Sight: FDA Approves ZUSDURI™, a Game-Changer for Relentless Bladder Cancer!

Historic First: ZUSDURI™ is the first and only FDA-approved medication for recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC).
Powerful Impact: Clinical trials show a remarkable 78% complete response rate at 3 months, offering new hope against a persistent disease^{2, 5}.
Beyond Surgery: Offers a non-surgical alternative for an estimated 59,000 U.S. patients annually who often face repeated, invasive procedures^{1, 8}.

For countless individuals battling recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC), life has been a grueling cycle of surgeries and the constant fear of recurrence. This persistent condition, often requiring multiple treatments, has long lacked a dedicated medicinal champion¹. But today, the landscape of bladder cancer treatment is irrevocably changed.

UroGen Pharma Ltd. has announced a monumental breakthrough: the U.S. Food and Drug Administration (FDA) has approved ZUSDURI™ (mitomycin) for intravesical solution. This isn't just another approval; it's the first and only FDA-sanctioned medication specifically for adults grappling with recurrent LG-IR-NMIBC^{1, 8}.

Powered by UroGen’s innovative RTGel™ reverse-thermal hydrogel technology, ZUSDURI™ delivers mitomycin directly to the bladder, ensuring sustained release for potent tumor ablation^{2, 5}. The results from the Phase 3 ENVISION trial are nothing short of extraordinary: 78% of patients achieved a complete response at three months. Even more impressively, 79% of these responders remained event-free twelve months later^{2, 5}.

"The approval of ZUSDURI represents a significant step forward," declared Liz Barrett, President and CEO of UroGen. "For the first time, the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine."

Dr. Sandip Prasad, principal investigator of the ENVISION trial, hailed ZUSDURI™ as a "breakthrough in uro-oncology," offering a desperately needed alternative to the endless cycle of transurethral resections (TURBT) under general anesthesia⁷.

While ZUSDURI™ brings profound hope, common adverse reactions included increased creatinine and potassium, dysuria, and urinary tract infection. Serious adverse reactions occurred in 12% of patients².

ZUSDURI™ is expected to be available in the U.S. around July 1, 2025. For more information, patients will soon be able to visit ZUSDURI.com. This landmark achievement signals a bold new era in the fight against bladder cancer, promising a brighter future for those who need it most.

Victory in Sight: FDA Approves ZUSDURI™, a Game-Changer for Relentless Bladder Cancer!

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