New Intravesical Therapy Approved for Non-muscle Invasive Bladder Cancer
The FDA has approved mitomycin intravesical solution for certain patients with recurrent non-muscle invasive bladder cancer.
The U.S. Food and Drug Administration (FDA) has approved mitomycin intravesical solution (Zusduri) for the treatment of adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have experienced recurrence after resection.
First approved as a cancer treatment in 1974, mitomycin is a naturally occurring compound produced by certain bacteria that can interfere with DNA replication and prevent cells from replicating. An example of chemotherapy, mitomycin is typically delivered intravenously to treat other cancer types, including stomach and pancreatic cancers. The newly approved formulation for bladder cancer, however, allows it to be delivered intravesically, meaning the therapeutic is delivered directly into the bladder via a catheter. The new formulation consists of mitomycin within a hydrogel to allow for sustained drug release after intravesical administration.
The approval of mitomycin intravesical solution was based on results from the single-arm, multicenter phase III ENVISION trial in which 240 patients with low-grade NMIBC received mitomycin intravesical solution. All patients had experienced disease recurrence after undergoing previous transurethral tumor resection of bladder tumor and also met at least one of the following criteria: multiple tumors, one tumor greater than three centimeters, and/or recurrence within one year of surgery.
At the three-month follow-up, 78% of the evaluable patients (174/223) had complete responses to mitomycin intravesical solution and no detectable disease in the bladder, and the majority (79%) of responses were sustained for at least one year.
The recommended dose for mitomycin intravesical solution is 75 mg instilled via a urinary catheter once weekly for six weeks.
Bladder cancer is a type of cancer that develops from the epithelial cells that line the bladder. Roughly 25% of bladder cancer cases invade the bladder muscle wall, with 75% classified as non-muscle invasive bladder cancer. According to federal statistics, it was estimated that 84,870 individuals would be diagnosed with bladder cancer and 17,420 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on June 12, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.