The FDA has approved Erbitux (cetuximab) for treating patients with advanced colorectal cancer that has spread to other parts of the body. It is the first monoclonal antibody approved to treat this type of cancer. It is indicated as a combination treatment with irinotecan.
Erbitux was approved under FDA's accelerated approval program. This allows approval of products for cancer and other serious diseases based on early evidence of a product's effectiveness.
|Erbitux was approved under FDA's accelerated approval program.|
Erbitux has been shown to shrink tumors in some patients and delay tumor growth, especially when used as a combination treatment. It is believed to work by targeting "epidermal growth factor receptor" (EGFR) on the surface of cancer cells, interfering with their growth.
Studies involving approximately 2000 patients are currently underway to assess the clinical benefits of Erbitux. These studies examine the ability of Erbitux to stop the progression of colorectal cancer and to extend patient survival.
The FDA has also approved a test kit used to analyze a colon tissue samples. It detects a protein in the body (HER-1) that stimulates cancerous tissue cell growth. The presence of this protein indicates that a patient is eligible for colon cancer treatment with Erbitux.