The U.S. Food and Drug Administration (FDA) just approved ZUSDURI (mitomycin) for adult patients with recurrent low-grade intermediate non-muscle invasive bladder cancer. The recommended dose is 75 mg into the bladder via urinary catheter once a week for six weeks.
ZUSDURI (mitomycin) is the first and only FDA-approved treatment option for adults with recurrent low-grade intermediate non-muscle invasive bladder cancer. ZUSDURI (mitomycin) was created for potent tumor ablation and consists of sterile hydrogel and mitomycin and uses UroGen’s own sustained-release RTGel® technology.
The FDA’s approval came after a pivotal phase 3 trial wherein 78% of patients achieved complete response at three months, and 79% of those patients maintained complete response for one year.
Common adverse reactions (≥10%) include decreased hemoglobin, decreased lymphocytes, decreased neutrophils, dysuria, hematuria, increased creatinine, increased eosinophils, increased potassium, and urinary tract infection.
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