Did you know?

About 75% of bladder cancers are non-muscle invasive bladder cancer (NMIBC). It forms only in the inner layer or lining of the bladder, known as the urothelium (yoo-roh-THEE-lee-um). The cancer has not reached the bladder's muscle wall. These cancers have a high survival rate—about 96% at 5 years—but they tend to recur (come back) after treatment.

NMIBC categories explained

NMIBC can be categorized by grade, stage, and risk level to help doctors choose the appropriate treatment:

Grade describes how abnormal or aggressive the cancer cells look and how fast they grow
Stage is how deep the cancer is and how far it has spread
Risk level reflects the chance of the cancer returning after treatment and the chance of it spreading

NMIBC Grades

NMIBC is described as either:

Low-grade (LG) slow-growing

High-grade (HG) fast-growing

Stages

NMIBC includes:

Stage 0 (Ta or Tis): Cancer cells are found only on the inner lining of the bladder and haven't spread deeper:
- Ta tumors grow toward the hollow center of the bladder and are considered the earliest stage
- Tis (also known as CIS) is a flat, more aggressive tumor
Stage 1 (T1): Cancer has moved just below the bladder lining into the connective layer, but has not reached the bladder muscle

MIBC (muscle invasive bladder cancer) includes:

Stage 2 (T2): Cancer has grown beyond the bladder lining, through the connective tissue, and into the muscle wall of the bladder. At this point, the cancer has become muscle invasive
Stage 3 (T3): Cancer has grown through the bladder wall and into the fatty layer outside the bladder
Stage 4 (T4): Cancer has spread beyond the bladder, possibly to lymph nodes or other organs

CIS=cancer in situ.

Diagram and text detailing bladder cancer stages: NMIBC (Stage 0, 1) and MIBC (Stage 2, 3, 4), with visual tumor representations.

Risk Levels

According to key treatment guidelines, the 3 risk levels for NMIBC include low, intermediate, and high^†:

Based on how much risk there is that the cancer will come back after treatment and the risk that it will spread
Depends on several factors, including stage, grade, size, and number of tumors, and how soon the cancer comes back

Risk Level	Characteristics of the Cancer
Low risk	Small, single, low-grade stage Ta tumor
Intermediate risk	Large, single, low-grade stage Ta tumor Multiple low-grade stage Ta tumors Low-grade stage Ta tumor that comes back within 1 year Low-grade stage 1 tumor Small, single, high-grade stage Ta tumor
High risk	Large or multiple high-grade stage Ta tumor(s) High-grade stage Tis tumor High-grade stage T1 tumor Stage Tis or T1 tumor with very high-risk features

Small=tumor that is 3 cm or smaller in size
Large=tumor that is greater than 3 cm in size

Focusing on Recurrent LG-IR-NMIBC

The standard treatment for LG-IR-NMIBC is TURBT (a surgical procedure to remove the tumors). This is sometimes followed by intravesical induction therapy with liquid-form chemotherapy or a type of immunotherapy called BCG. This may be followed by more doses as maintenance therapy for up to one year. Despite current treatments, LG-IR-NMIBC will often recur (come back). Upon recurrence, patients will often undergo repeat surgery.

There is now a different approach to treating recurrent LG-IR-NMIBC.

BCG=bacillus Calmette-Guérin; LG-IR-NMIBC=low-grade intermediate-risk non-muscle invasive bladder cancer; TURBT=transurethral resection of bladder tumor.
*Compensated for his time.
^†According to American Urological Association/Society of Urologic Oncology guidelines.

APPROVED USE FOR ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after you have previously received bladder surgery to remove tumor and it did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems
are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.

How will I receive ZUSDURI?

You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving ZUSDURI:

ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.

Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, blood in your urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Understandingrecurrent LG-IR-NMIBC