FDA Approval Alert: The Need-to-Know | Intravesical Mitomycin Solution in Low-Grade Intermediate-Risk NMIBC

In June 2025, the FDA approved an intravesical formulation of mitomycin (UGN-102) as a treatment for patients with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.
FDA Approves Mitomycin Solution in Low-Grade Intermediate-Risk NMIBC
Article
Jun 12, 2025 4:53 PM
Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.