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Survival Data in FDA Approval for ERBITUX(R) (Cetuximab) Supports use as a Single Agent in Patients with Advanced Colorectal Cancer
Date:10/2/2007

he only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb. "We continue to be encouraged by the benefits of ERBITUX in metastatic colorectal cancer, and are actively exploring its potential in other tumor types."

About Colorectal Cancer

In the U.S., approximately 154,000 people will be diagnosed with cancer of the colon or rectum this year. More than half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in 60-80 percent of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women, excluding skin cancer.

About ERBITUX(R) (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX's anti- tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

ERBITUX, as a single agent, is indicated for the treatment of EGFR- expressing, metastatic colorectal carcinoma (mCRC) after failure of both irinotecan-and oxalip
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SOURCE Bristol-Myers Squibb Company; ImClone Systems Incorporated
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