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FDA Approves Erbitux (Cetuximab), First Head & Neck Cancer Treatment in 45 Years

Data Shows Treatment with Erbitux Extends Survival

BETHESDA, M.D. -- March 2, 2006 -- The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN).

This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy.

"Patients suffering from all forms of cancer have a common goal – to treat the disease and prolong life," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible."

Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone.

Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13% of patients, lasting on average of 6 months. Standard cancer statistics databases estimate that there are about 29,000 new cases of head and neck cancer diagnosed every year in the United States.

The safety and effectiveness of Erbitux was established in two studies. The randomized clinical trial of 424 patients using Erbitux in combination with radiation therapy showed a survival time of 49 months versus 29.3 months on radiation therapy alone. In addition, delay in tumor growth was observed with the use of Erbitux and radiation, compared to radiation alone.

Since tumor growth is associated with pain, difficulties swallowing, speaking and eating, control of tumor growth as long as possible is important for the patients' well being. In a second trial of 103 patients with recurrent or metastatic SCCHN, Erbitux helped to shrink the patients' tumors after the tumors no longer responded to platinum-based therapy, the current standard treatment for patients with this difficult to treat disease.

Commonly reported side effects of Erbitux were infusion reactions (fever, chills), skin rash, fatigue/malaise, nausea. The common side effects associated with radiation such as sore mouth, trouble swallowing, and radiation skin changes were similar in frequency in patients receiving Erbitux plus radiation and those receiving radiation alone.

Erbitux is manufactured by ImClone Systems Inc., Branchburg, NJ and will be distributed and marketed by Bristol- Myers Squibb Co., Princeton, NJ.


SOURCE: Food and Drug Administration

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