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COPYRIGHT 2005 Business Wire
NEW YORK & PRINCETON, N.J. -- ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has notified ImClone Systems that it has accepted for filing the Company's supplemental Biologics License Application (sBLA) for ERBITUX(R) (Cetuximab), an IgG1 monoclonal antibody, in the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The application seeks approval for use of ERBITUX in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate.
The Companies also announced that the ERBITUX sBLA has been granted priority review. The FDA grants priority review to biologics that potentially offer a significant therapeutic advance over existing therapies for serious or life-threatening diseases. Based on the priority review designation, the FDA has six months from the submission date of August 30, 2005, to take action on the sBLA filing.
About Head and Neck Cancer
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, it...
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