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- FDA Approves Mitomycin Intravesical Solution for Recurrent . . .
On June 12, 2025, the U S Food and Drug Administration (FDA) approved mitomycin intravesical solution (Zusduri ™) for adult patients with recurrent low-grade, intermediate-risk, non–muscle invasive bladder cancer (NMIBC)
- FDA Approves First Nonsurgical Treatment for Recurrent, Low . . .
Administration: The treatment involves six weekly instillations (once per week for six weeks) of mitomycin solution into the bladder via a urinary catheter Who Is Eligible: Adult patients with recurrent, low-grade, intermediate-risk NMIBC This includes those with multiple tumors, a single tumor at least 3 cm in size, or frequent recurrences
- FDA Approves Zusduri (mitomycin) for Recurrent Low-Grade . . .
Our first product to treat low-grade upper tract urothelial cancer and Zusduri (mitomycin) for intravesical solution, UroGen’s first product to treat recurrent LG-IR-NMIBC are both designed to ablate tumors by non-surgical means
- Comparisons of Intravesical Treatments with Mitomycin C . . .
Our findings corroborate the current guidelines indicating that both gemcitabine and mitomycin C are effective treatments that reduce tumor recurrence and improve survival of non-muscle-invasive bladder cancer, although with large variability across studies
- FDA approves mitomycin intravesical solution for recurrent LG . . .
On June 12, 2025, the FDA approved mitomycin for intravesical solution (Zusduri; formerly UGN-102) for the treatment of adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC), the agency announced in a news release 1
- Mitomycin Intravesical Solution Approved for Low-Grade Non . . .
The FDA has granted approval to mitomycin intravesical solution (Zusduri™, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC)
- FDA Approves Intravesical Mitomycin for Recurrent, Low-Grade . . .
Mitomycin intravesical solution (Zusduri; UGN-102) is FDA-approved for recurrent, low-grade, intermediate-risk NMIBC, based on the phase 3 ENVISION trial results The ENVISION trial showed a 78%
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