THURSDAY, Feb. 12, 2004 (HealthDayNews) -- The anti-cancer drug at the center of the Martha Stewart scandal won U.S. Food and Drug Administration approval Thursday, the FDA announced.
While the agency said ImClone's Erbitux didn't extend the lives of patients with advanced colon cancer, trials did show that it shrank tumors in some people and delayed tumor growth, especially when combined with another chemotherapy drug.
In 2001, the FDA rejected the company's first application, saying the firm's clinical trials were poorly designed and conducted. The charges against Stewart focus on her sale of ImClone's stock shortly before the FDA announced the rejection. She is charged with lying to investigators and securities fraud, but not insider trading. The company's former president is in jail for his role in the scandal.
Known as a monoclonal antibody, Erbitux (cetuximab) contains proteins engineered to target molecules that cancer cells need to grow, thus shrinking tumors. And its side effects reportedly are often more tolerable than conventional chemotherapies.
Colorectal cancer is the third most common cancer in the United States and is the second-leading cause of cancer-related death, the U.S. Centers for Disease Control and Prevention says. Some 147,500 cases were diagnosed in 2003.
For more information about colorectal cancer, visit the National Library of Medicine's Medline Plus site.
