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ImClone Files for New Erbitux Use

The company asks the FDA to approve Erbitux as a treatment for head and neck cancer.
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ImClone Systems


submitted an application to U.S. regulators that seeks approval to expand the use of its cancer drug Erbitux.

The company is asking the Food and Drug Administration to approve Erbitux as a treatment for squamous-cell carcinoma of the head and neck. The FDA approved Erbitux in February 2004 for use against colorectal cancer.

ImClone now wants approval to market the drug for use with radiation for locally or regionally advanced head and neck cancer, and as a single treatment in patients with recurrent or metastatic head and neck cancer for whom prior platinum-based chemotherapy has failed or for whom that treatment wouldn't be appropriate.

Merck KGaA

, ImClone's development and marketing partner for Erbitux outside North America, filed a similar application with European and Swiss regulators. Merck KGaA, which is based in Germany, isn't affiliated with

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Merck & Co.

of Whitehouse Station, N.J.

ImClone markets the drug in the U.S. with

Bristol-Myers Squibb

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Earlier this year, ImClone said it would likely file for approval to use Erbitux in treating head and neck cancer by the end of 2005. The company had delayed the expected filing date from its previous second-quarter target.