Erbitux Gets Priority Status for Head, Neck Cancer Review
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31 October, 2005 22:42 GMT
The FDA will review Erbitux as a treatment for head and neck cancer within six months instead of the usual 10.
ImClone Systems Inc. and
Bristol-Myers Squibb Co. said Monday that US regulators have granted a priority review for a new use for the companies' colon-cancer drug Erbitux.
The companies are seeking to market the drug to treat localized head and neck cancers along with radiation, or for use by itself in treating head and neck cancers that have returned or spread in cases where chemotherapy has failed or is not appropriate.
11,000 Die from the Disease
Priority status means the
Food and Drug Administration will review the marketing application within six months of its submission rather than the standard 10 months. The companies submitted the application Aug. 30.
Every year about 40,000 people in the United States are diagnosed with head and neck cancers and about 11,000 die from the disease.
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