ImClone, Bristol-Myers get FDA approval of Erbitux for head and neck cancer

New York, March 1 - ImClone Systems Inc. and Bristol-Myers Squibb Co. said the Food and Drug Administration approved Erbitux (Cetuximab) for the treatment of squamous cell carcinoma of the head and neck.

Erbitux is the first and only monoclonal antibody to be approved for the treatment of head and neck cancer, the companies said.

The drugs is an IgG1 monoclonal antibody designed to inhibit the function of the epidermal growth factor receptor (EGFR), a molecular structure linked to tumor growth.

Erbitux will be used in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck and as a single agent in recurrent or metastatic squamous cell carcinoma of the head and neck where prior platinum-based chemotherapy has failed.

The approval is based on a phase 3 study that demonstrated a survival and locoregional control advantage when Erbitux was added to radiation therapy, and a phase 2 study, where Erbitux therapy alone reduced tumor size.

"This is an important milestone as Erbitux is the first FDA approved therapy for head and neck cancer patients in more than 30 years," said Kie-Kian Ang, professor, radiation oncology, deputy chair, radiation oncology, deputy division head, radiation oncology at The University of Texas M. D. Anderson Cancer Center in Houston, in a news releas. "For patients with locally or regionally advanced disease, Erbitux in combination with radiation therapy has demonstrated a clinically significant improvement in survival and locoregional control."

The FDA previously approved Erbitux for use in combination with irinotecan for patients with EGFR-expressing metastatic colorectal cancer who are refractory to irinotecan therapy and as a single-agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan therapy.

ImClone develops biologic treatments designed to address the medical needs of patients with a variety of cancers. Headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, N.J..

New York-based Bristol-Myers Squibb is a global pharmaceutical and related health care products company.

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