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FDA reviews new use for Erbitux
Colorectal drug from Bristol-Myers and ImClone now being weighed for head and neck cancer treatment.
October 31, 2005: 10:09 AM EST
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - The FDA granted priority review status to an additional use for Erbitux, an anti-cancer drug produced by partners Bristol-Myers Squibb and ImClone Systems, the companies said Monday.

Erbitux, which was approved in 2004 for the treatment of colorectal cancer, is also being reviewed by the Food and Drug Administration for an additional use, the treatment of head and neck cancer, which affects 40,000 Americans annually.

The FDA often grants priority review status for anti-cancer drugs, and had given Erbitux priority review when it was approved for its original purpose on Feb. 12, 2004.

Erbitux sales for the first nine months of 2005 totaled $292 million, up from $173 million during the same period last year, said Bristol-Myers (unchanged at $21.14, Research) spokesman Tony Plohoros. Just in the third quarter of 2005, Erbitux sales totaled $107 million, said Plohoros.

Stock prices rose about two percent Monday morning for ImClone (Research). On June 7, 2004, the day before Imclone unveiled clinical positive data for Erbitux's effect on head and neck cancer, financier Carl Icahn acquired a stake in the drugmaker.

The New York City biotech dominated headlines in 2001 when insider trading resulted in the convictions of former chief executive officer Sam Waksal and celebrity homemaker and stockholder Martha Stewart.

To read more about Erbitux, click here.  Top of page

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