FDA expedites review of Erbitux for head, neck cancers | VailDaily.com
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FDA expedites review of Erbitux for head, neck cancers

NEW YORK – ImClone Systems Inc. and Bristol-Myers Squibb Co. said Monday that the Food and Drug Administration 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.Priority status means the FDA will review the marketing application within six months of its submission rather than the standard ten 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.Shares of New York-based ImClone rose 62 cents, or 1.8 percent, to close at $34.70 Monday on the Nasdaq Stock Market. The stock has traded in a 52-week range between $29.51 and $47.79.


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