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BAVENCIO® (avelumab) is an immunotherapy—a medicine that may help your immune system fight locally advanced or metastatic urothelial carcinoma (UC)

BAVENCIO is used after UC has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains platinum, and it did not work or is no longer working

BAVENCIO is a man-made antibody. Your body naturally produces antibodies to help your immune system work.

BAVENCIO is approved by the Food and Drug Administration (FDA) to treat patients whose disease has gotten worse either while on or after completing a type of chemotherapy that contains platinum. 

BAVENCIO is delivered by an intravenous (IV) infusion directly into your bloodstream.

A clinical trial tested if BAVENCIO could help patients with locally advanced or metastatic UC who had already received chemotherapy for cancer that had spread

16.1%

of patients who were monitored for at least 6 months during the trial (26 out of 161) saw their tumors get smaller while taking BAVENCIO

  • 5.6% (9 of 161) of patients saw their tumors disappear (complete response)
  • 10.6% (17 of 161) of patients saw their tumors shrink (partial response)

Among the 26 patients whose tumors got smaller:

85%(22 patients) maintained their response to treatment for at least 6 months

15%(4 patients) maintained their response for at least 1 year

What is the most important information I should know about BAVENCIO?

BAVENCIO can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Urothelial carcinoma (UC), a form of bladder cancer, is relatively common

Most bladder cancers develop in the innermost lining of the bladder, called the urothelium. If the cancer grows into the other layers of the bladder wall, it becomes more advanced and can be harder to treat.

UC develops in cells of the urinary system. While 90% of UC is found in the bladder, UC may also occur in parts of the kidney, ureter, or urethra.

Bladder cancer is the sixth most common cancer in the United States, with approximately 79,030 new diagnoses a year.

UC is the most common type of bladder cancer. In fact, approximately 90% of all bladder cancers are UC.

Common bladder cancer symptoms can include blood in the urine, back and pelvic pain, swelling in the feet, weight loss, and bone pain.

Over time, cancers such as UC can spread throughout your body.

When tumors spread to nearby tissue or lymph nodes, it is called locally advanced. When tumors spread to other parts of your body, it’s called metastatic.

Urine tests—A procedure where doctors examine certain features or abnormal-appearing cells in the urine.

Imaging tests—Imaging tests can help to detect any masses or abnormalities in the kidneys, ureters, bladder, or urethra.

Cystoscopy—A procedure that is done to examine the lining of the urethra and bladder.

There are a number of ways to treat this type of cancer. Four common treatments are:

  • Surgery, which removes cancer cells from the body
  • Chemotherapy, which kills cancer cells
  • Radiation therapy, which uses high-energy radiation on cancer cells
  • Immunotherapy, which helps your immune system kill cancer cells

Your doctor may also consider whether a clinical trial is right for you.

Smoking—People who smoke cigarettes are more likely to develop bladder cancer compared to people who have never smoked. Exposure to secondhand smoke also increases the risk.

Personal or family history of cancer—People who’ve had bladder cancer are more likely to get it again. Having a family history of bladder cancer may increase the risk of developing this disease. A family history of Lynch syndrome can also increase your risk of developing cancer in your urinary system.

Increasing age—Your risk of bladder cancer increases as you age. Bladder cancer can occur at any age, but it’s rarely found in people younger than 40.

Being a man—Men are more likely to develop bladder cancer than women.