The FDA said it approved the new use for the drug based on a study that showed Erbitux, in combination with radiation therapy, prolonged the lives of head and neck cancer patients by 20 months compared to treatment with radiation alone.

The Food and Drug Administration initially approved the drug in 2004 to treat colorectal cancer. The drug may now be used in combination with radiation to treat patients with squamous cell cancer of the head and neck that cannot be removed by surgery.

It was also approved Wednesday for use by itself to treat patients whose cancer has spread despite treatment with standard chemotherapy.

29,000 New US Cases per Year

Erbitux is made by ImClone Systems Inc. and distributed by Bristol-Myers Squibb Co., both of which are based in New York.

Erbitux, formally known as cetuximab, was the drug at the center of the ImClone Systems stock scandal that sent Martha Stewart and ImClone founder Sam Waksal to prison.

About 29,000 Americans are diagnosed with head and neck cancer a year, according to the FDA. The group includes cancers of the tongue, mouth, pharynx and larynx.

More Effective When Used With Another Drug

The FDA said it approved the new use for the drug based on a study that showed Erbitux, in combination with radiation therapy, prolonged the lives of head and neck cancer patients by 20 months compared to treatment with radiation alone.

Previously, the FDA said Erbitux had not been shown to extend the lives of colorectal cancer patients. However, studies have shown the drug to shrink some tumors and delay the growth of others, especially when used with another cancer drug.