Erbitux receives federal approval as first new head and neck cancer drug since 1950s

U.S. government regulators Wednesday approved Erbitux as the first new drug to treat head and neck cancer since the 1950s.

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

Erbitux is made by ImClone Systems Inc and distributed by Bristol-Myers Squibb Co. .

The drug is meant to be used in combination with radiation or by itself in patients whose cancer has spread despite treatment with standard chemotherapy, the FDA said.

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.

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

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, reports AP.


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