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FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
Date:11/7/2011

SILVER SPRING, Md., Nov. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.

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Combined with chemotherapy, Erbitux extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone. Erbitux already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).

According to the National Cancer Institute, head and neck cancers account for 3 percent to 5 percent of all cancers in the United States. These cancers typically develop in the nose, throat or mouth and they are more common in men and in people older than 50.

"Erbitux's ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multi-treatment approach for patients," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Drug Products in the FDA's Center for Drug Evaluation and Research." Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible."

The safety and effectiveness of Erbitux for this indication is based on the results of a multi-center clinical study conducted outside the United States involving 442 patients with metastatic or recurrent head and neck cancer. The study used a non-U.S. approved version of cetuximab, rather than the U.S.-approved formulation.

Participants had inoperable or widespread disease and had not received prior chemotherapy. Half
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SOURCE U.S. Food and Drug Administration
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