WASHINGTON, Sept. 27 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Thursday approved Stivarga to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body.
Stivarga, marketed by Bayer HealthCare Pharmaceuticals, is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth.
The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to best supportive care ( BSC), which includes treatments to help manage side effects and symptoms of cancer. Study results showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC.
According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer and the third leading cause of cancer death in the United States. The National Institutes of Health estimates 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012.