- The U.S. FDA has approved UroGen Pharma's ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- The approval is based on Phase 3 ENVISION trial results showing a 78% complete response rate at 3 months, with 79% of those patients maintaining response at 12 months.
- ZUSDURI is expected to be available in the U.S. from July 1, 2025, offering a non-surgical treatment alternative for bladder cancer patients.
UroGen Pharma Ltd. (URGN, Financial) has announced that the U.S. Food and Drug Administration (FDA) has approved ZUSDURI™ (mitomycin) for intravesical solution as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The approval is a significant milestone, providing an alternative to the standard surgical procedure known as transurethral resection of bladder tumor (TURBT).
This landmark approval is backed by the pivotal Phase 3 ENVISION trial, which demonstrated a complete response (CR) in 78% of patients at 3 months, with 79% maintaining that response 12 months later. ZUSDURI utilizes UroGen's proprietary RTGel® technology for delivering potent tumor ablation directly into the bladder through a urinary catheter, offering a non-surgical treatment option for patients.
An estimated 59,000 patients in the U.S. suffer from recurrent LG-IR-NMIBC annually, facing the challenge of repeat surgeries. ZUSDURI's approval provides these patients with a new treatment path. The most common adverse effects reported include increased creatinine and potassium levels, dysuria, and hematuria, alongside serious reactions like urinary retention. Despite these, ZUSDURI maintains a manageable safety profile.
The biotech company plans to make ZUSDURI available in the U.S. by July 1, 2025. In addition, UroGen has committed to finishing the ongoing ENVISION trial to further assess ZUSDURI's clinical benefit and will provide annual updates to the FDA on the duration of patient responses. For those interested in further details, UroGen will host a live conference call and webcast on June 13, 2025, at 8:30 AM ET.
UroGen Pharma Ltd., headquartered in Princeton, NJ, continues to make strides in biotech innovation, focusing on urothelial and specialty cancers with its proprietary RTGel® technology.
