Zusduri approved for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Executive Summary
Efficacy was evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor (TURBT)
Among the 223 patients evaluable for response, 78% (95% CI: 72, 83) had a CR. The DOR ranged from 0 to 25+ months and 79% of responding patients remained in response for at least 12 months.
Serious adverse reactions occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in 1 patient.
Quote:
“The recent FDA approval of ZUSDURI for the treatment of adults with recurrent LG-IR-NMIBC represents a truly transformative milestone for patients and for UroGen, marking our evolution into a multi-product uro-oncology company and our leadership in the field,” said Liz Barrett, President and Chief Executive Officer of UroGen
