Zusduri (mitomycin) is a chemotherapy medicine that was approved by the FDA in June 2025 for the treatment of a specific type of bladder cancer known as recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It has been shown to kill cancer cells in adults with LG-IR-NMIBC who have previously had transurethral resection of bladder tumor (TURBT), a procedure that removes visible cancer from the bladder.
What Is Zusduri Used For?
Zusduri is used to treat a certain type of recurrent, persistent bladder cancer known as LG-IR-NMIBC. About 75% of people with bladder cancer present with non-muscle invasive bladder cancer (NMIBC), which means the cancer has not grown into the bladder wall. The cancer can be ranked as being at a low risk, intermediate risk, or high risk of progression (getting worse) or recurrence (coming back after treatment). In people with LG-IR-NMIBC, there are either multiple tumors or one large tumor in the bladder.
How Is Zusduri Given?
Zusduri is a type of chemotherapy that is delivered to the bladder through the urethra. The urethra is the tube that pee comes out of. Your health care provider will thread a soft, thin catheter through your urethra, leave it in during each treatment session, and then take it out. Zusduri is given by a health care provider in their office or clinic.
Before Zusduri goes in, it is chilled so it becomes a liquid and is easier to deliver. Once the medicine is in your bladder, it will become a gel as it warms up. Since you will pee out the medicine, you will see gel in your urine for the first 24 hours after each treatment.
Zusduri is given once a week into the bladder for six weeks. It is important that you receive all six doses of Zusduri. If you miss any appointments, call your health care provider as soon as possible to reschedule your appointment.
How Was Zusduri Studied for Bladder Cancer?
One ongoing clinical study known as ENVISION looked at whether Zusduri was safe and effective for treating LG-IR-NMIBC at three months and onward after therapy. Zusduri was not compared to any other medicine or placebo. People in the study knew that they were receiving Zusduri.
The ENVISION study included 240 adults diagnosed with Ta disease (cancer is not yet in bladder tissue or muscle) LG-IR-NMIBC. The diagnosis of LG-IR-NMIBC was confirmed using a tissue sample (biopsy) from the bladder that had to contain either multiple tumors or one large tumor bigger than 3 centimeters, and people had to have early or frequent recurrence of their cancer (at least one recurrence within one year of the current diagnosis). People also had to have a previous occurrence of LG-NMIBC that was treated with TURBT. People were excluded from the study if they had a T1 tumor (cancer is in bladder tissue but is not yet in the muscle), a history of high-grade (cancer is more likely to come back or progress) NMIBC within the last two years, and if they had received prior bladder chemotherapy within the last two years (unless they had only received a single dose after TURBT), or had received Bacillus Calmette-Guerin (BCG) for bladder cancer within the last year.
Zusduri was given through a catheter into the bladder once weekly for six doses. The average age of people in the study was about 70 years (range: 30 to 92 years). About 62% of people were male and 38% were female. Almost 98% of the people were White, 0.9% were Black, 0.9% were Asian, 0.4% were not reported, and 1.3% were Hispanic or Latino. Most people in the study (84%) had multiple tumors, 6% had a tumor bigger than three centimeters, 55% had a prior occurrence of LG-NMIBC within the last year of their current diagnosis, and all people had received prior TURBT.
Every three months, the status of the cancer in the bladder was assessed. The goal of the study was to see whether people had a complete response (no detectable cancer in the bladder) after three months, and to see how long people remained cancer-free after receiving Zusduri. Although results are only available for the first 12 months of the study, people in the study who remain cancer-free will continue to be assessed for up to five years and their results will be published later.
What Benefits Were Seen With Zusduri?
Zusduri resulted in complete response (no detectable cancer in the bladder) in 78% of people at three months. In the people that achieved a complete response, 79% had their response last for 12 months or longer.
Your results may differ from what was seen in clinical studies.
What Can I Do to Manage Side Effects?
The most common side effects of Zusduri include painful urination, a bladder or kidney infection, blood in the urine, and abnormal blood tests. These side effects can be similar to symptoms of bladder cancer or urinary tract infections, and you should tell your health care provider if they happen. Your health care provider will be monitoring you with blood tests, so they will be aware if there is an abnormal blood test. Make sure to keep all of your appointments with your health care provider to get your blood checked.
What Are Other Unique Considerations to Be Aware Of?
Zusduri may turn your pee blue or purple in color. Try to avoid getting your pee anywhere on your skin for the first 24 hours after each treatment. Sitting on the toilet to pee can help you avoid getting it on your skin. Make sure to wash your hands and private area with soap and water each time after you go to the bathroom. You should also flush your toilet several times after each use.
Since Zusduri should not be used during pregnancy, women who can become pregnant should use birth control (contraception) during treatment with Zusduri, and for six months after the last dose of treatment. Males who have female partners who can become pregnant should also use effective birth control (contraception) during treatment with Zusduri, and for three months after the last dose.
Is There Any Cost Assistance Available for Zusduri?
There may be cost assistance to help you afford Zusduri. If you do not have insurance, you may qualify for the UroGen Support Patient Assistance Program. Your health care provider can help you get started, or you can call 833-876-4361.
Patients can learn more about Zusduri at www.zusduri.com/patient/resources/.
