Zusduri Approved for Recurrent Low-Grade Intermediate-Risk Non–Muscle-Invasive Bladder Cancer

The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer (NMIBC).

Efficacy was evaluated in ENVISION (ClinicalTrials.gov Identifier: NCT05243550), a single-arm, multicenter trial in 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor and met one to two of the following criteria: multiple tumors, a solitary tumor larger than 3