NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The application, submitted on August 29, 2008, was prepared in conjunction with Bristol-Myers Squibb Company, ImClone’s partner for ERBITUX in North America. ImClone has requested Priority Review of the application, which, if granted, means that the FDA would make a decision on the application within six months. The FDA will notify ImClone whether it has accepted the submission by the end of October.
