UroGen Pharma announces FDA approval of Zusduri for LG-IR-NMIBC

UroGen Pharma (URGN) announced the U.S. FDA approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel technology. ZUSDURI has been designed for potent tumor ablation. This landmark approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response for patients at 3 months, and of those patients 79% remained event-free 12 months later, UroGen said. “The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC,” said 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. This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most. We are deeply grateful to the FDA for their collaboration and to the investigators, patients, and caregivers whose commitment made this milestone possible. Their contributions have been essential in bringing meaningful innovation to the bladder cancer community.” ZUSDURI is expected to be available in the U.S. on or around July 1, 2025, for the treatment of adults with recurrent LG-IR-NMIBC.