FDA OKs High-Tech Colon Cancer Treatment
Erbitux Shrinks Tumors, Delays Progression
The FDA first evaluated Erbitux in December 2001 after its manufacturer ImClone submitted an application for approval. The FDA rejected Erbitux in December 2001, saying that important safety and effectiveness data were missing. Prosecutors say Martha Stewart lied about unloading her ImClone shares at that time after she received inside information and then tried to obstruct an investigation.
In their new request for approval, Imclone submitted the results of a large, well-run trial that included 329 patients as well as the results of the earlier two studies. For the studies submitted in their original 2001 request for approval, ImClone successfully collected substantial amounts of missing information from hospital records and other sources.
"The FDA staff work hard to ensure doctors and patients can have confidence in the safety and effectiveness of new therapies such as Erbitux," says Mark B. McClellan, MD, PhD, in a news release. "FDA believes it is crucial for cancer patients to have many proven treatment options in their battle against this disease."
Two studies involving approximately 2,000 patients are currently underway to assess the clinical benefits of Erbitux. These studies are specifically examining the ability of Erbitux to stop the progression of colon cancer and to extend the amount of time patients survive with the disease.
Erbitux can cause serious side effects, usually during the administration of the first treatment, which may include difficulty breathing and low blood pressure. Rarely, a condition known as interstitial lung disease (ILD) has been reported; however, it is difficult to determine if Erbitux caused ILD, the FDA says. ILD occurs when the lung becomes stiff because of scarring of the tissue between the air sacs of the lungs.
Other more common side effects of Erbitux treatment are:
Colon cancer is the third most common cancer affecting men and women in the U.S., according to the CDC, and is the second leading cause of cancer-related death. Colorectal cancer is also one of the most commonly diagnosed cancers in the U.S.; approximately 147,500 new cases were diagnosed in 2003.