FDA Bucks Advisors to Approve Mitomycin for Non-Muscle Invasive Bladder Cancer

RX Review: Redefining treatment for LG-IR-NMIBC

In this video, part 1 in a 5-part series, panelists discuss how mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri) fits into the evolving management landscape for recurrent bladder tumors.

FDA Bucks Advisors to Approve Mitomycin for Non-Muscle Invasive Bladder Cancer

The agency set aside concerns about UroGen’s approval trial to greenlight mitomycin intravesical solution for recurrent non-muscle invasive bladder cancer.

Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Mitomycin intravesical solution is the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer.

FDA Approves Mitomycin Solution in Low-Grade Intermediate-Risk NMIBC

Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.