Expanded use sought for colon cancer drug

Nov 1 2005

Approval is being sought for a drug designed to treat colon cancer to be used also for the treatment of head and neck cancers.

ImClone Systems and marketing partner Bristol-Myers Squibb say U.S. regulators have accepted their application to market the colon cancer drug Erbitux for the treatment of head and neck cancer.

The U.S. Food and Drug Administration have apparently given the application a "priority review" status, which gives the agency six months from the submission date to take action.

In the application approval is being sought for the use of Erbitux in combination with radiation for locally or regionally advanced head and neck cancer, and also as monotherapy in patients with recurrent and/or metastatic disease where prior chemotherapy has failed or would not be appropriate.