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JUNE 14, 2025

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


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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