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news.ImClone Systems has asked the FDA to review an application for the use of cancer drug Erbitux in the treatment of head and neck cancer. The drug is already co-marketed with Bristol-Myers Squibb as a treatment of colorectal cancer.
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The application seeks US marketing approval for the use of Erbitux in combination with radiation, and with recurrent and/or metastatic head and neck cancer where prior platinum-based chemotherapy has failed, or where platinum based therapy would not be appropriate.
At the same time, Merck KGaA, ImClone Systems’ development and marketing partner for Erbitux outside of North America, has filed a Variation Application to the European Medicines Agency (EMEA) and to the Swiss authority (Swissmedic) for approval of the drug in the head and neck indication.
According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. In addition, is it estimated that more than 11,000 will die from the disease in 2005 in the US.