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FDA OKs High-Tech Colon Cancer Treatment

Erbitux Shrinks Tumors, Delays Progression

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"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:

  • Acne-like rash
  • Dry skin
  • Tiredness or weakness
  • Fever
  • Constipation
  • Abdominal pain

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.

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