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【FDA Approval Alert】UroGen Pharma’s mitomycin (Zusduri) Approved for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (June 12, 2025)
On June 12, 2025, the U.S. FDA approved mitomycin (Zusduri) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval is based on the results of the ENVISION trial (NCT05243550), utilizing intravesical instillation therapy.
Disease Overview: Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC refers to bladder cancer that remains within the inner lining and often recurs locally. Following TURBT surgery, intravesical therapy is administered to reduce recurrence risk.
Treatment Summary
- Drug Name: mitomycin (Zusduri)
- Company: UroGen Pharma
- Approval Date: June 12, 2025
- Indication: Recurrent low-grade intermediate-risk NMIBC (LG-IR-NMIBC)
- Mechanism of Action: Local cytotoxic effect via alkylating agent
- Pivotal Trial: ENVISION (NCT05243550)
- Key Efficacy: 78% complete response at 3 months; response duration up to 25+ months
Patient-Friendly Summary
Zusduri is delivered directly into the bladder to target tumor cells locally and helps reduce recurrence for patients with non-muscle invasive bladder cancer.
M&A Information
- Subsidiary: Not applicable (UroGen Pharma in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NASDAQ: URGN)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
