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Updated Labeling for Cetuximab Includes Overall Survival Data

NEW YORK, Oct. 2 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (NASDAQ:IMCL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the cetuximab (Erbitux) product labeling to include overall survival data as a single agent in epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer (mCRC) patients after failure of both irinotecan- and oxaliplatin-based regimens.

The approval of the supplemental biologics license application (sBLA) is based on prolonged overall survival from a large, randomized, multicenter, Phase III trial comparing Erbitux plus best supportive care (BSC) to BSC alone in 572 EGFR-expressing mCRC patients after failure of irinotecan- and oxaliplatin-based regimens. BSC was considered to be all approved palliative therapies designed to alleviate pain and treat other effects caused by mCRC in this patient population.

"We are very pleased that the FDA has recognized these data as the second disease setting where ERBITUX has improved overall survival - which is the ultimate goal of all cancer therapies," said Eric K Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "This approval for Erbitux as a monotherapy offers an additional treatment option for an expanded patient population, specifically, patients who have failed both irinotecan- and oxaliplatin-based chemotherapy regimens."

"Erbitux is now the 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 oxaliplatin-based regimes. Erbitux, as a single agent, is also indicated for the treatment of EGFR-expressing mCRC in patients who are intolerant to irinotecan-based regimens.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit https://www.erbitux.com/.

Source: Bristol-Myers Squibb Company and ImClone Systems

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