Statement of Need

In 2010, it was estimated there were 70,530 new cases of bladder cancer diagnosed in the United States, with 14,680 deaths occurring from the disease.

Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women. It ranks as the third most common cancer and the ninth leading cause of cancer death in men. Each year in the United States, more than 52,000 men and 18,000 women are diagnosed with bladder cancer. More than 9 out of 10 Americans with bladder cancer have a type called transitional cell cancer (TCC) — cancer that begins in cells that normally make up the inner lining of the bladder. TCC is the most common form of bladder cancer, accounting for more than 90% of all bladder cancers. There are no approved agents for the treatment of advanced or metastatic relapsed TCC of the urinary bladder. It is expected that the incidence of bladder cancer will continue to increase concurrent with an increase in industrialization, lifestyle factors, and an aging population. In the United States, over 500,000 people are survivors of this cancer. Most of the patients with bladder cancer require frequent follow up and treatment, some as often as two to four times per year.

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