FDA OKs Drug for Head & Neck Cancer

March 2, 2006 -- The FDA has approved Erbitux, a drug to help treat cancer of the head and neck.

Erbitux is designed for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that cannot be removed by surgery. It's the first drug approved for head and neck cancer that has shown a survival benefit in this population, according the FDA.

The FDA also approved Erbitux to be used without other drugs (monotherapy) in treating patients whose head and neck cancer has spread despite the use of standard chemotherapy.

Head and Neck Cancers

Head and neck cancers are more common in men and in people over age 50.

Tobacco, including chewing tobacco, and alcohol are factors that increase the risk of these cancers. Head and neck cancers affect the mouth, nose, sinuses, and throat.

Because of the location of these cancers, people affected often have significant problems with swallowing and speaking.

The FDA's Comments

"Patients suffering from all forms of cancer have a common goal -- to treat the disease and prolong life," says Steven Galson, MD, MPH, in an FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.

"We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer," Galson continues.

"The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible," Galson says.

First New Drug Approved in Decades

Erbitux, which received a priority review from the FDA, is the first drug approved by the FDA to treat head and neck cancer since methotrexate became available in the 1950s.

Approval of Erbitux in combination with radiation therapy was based on a study showing that Erbitux prolonged survival by more than a year and a half, compared with treatment with radiation alone.

Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13% of patients, lasting on average of six months.

Every year, about 29,000 new cases of head and neck cancer are diagnosed in the U.S., according to the FDA.

About Erbitux

Unlike many chemotherapy drugs that work by poisoning cancer cells, Erbitux is an antibody. Erbitux blocks the effect of a major growth factor that is responsible for causing cancers to grow.

Erbitux is also used in other cancers, such as colorectal cancer.