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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Erbitux for head and neck cancer: Bristol-Myers Squibb/ImClone's Erbitux (cetuximab) is cleared March 1 for use in combination with radiation therapy for treatment of "locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)" and as monotherapy for "patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed." The epidermal growth factor receptor inhibitor is the first agent approved for head and neck cancer that has shown a survival benefit, FDA notes. Erbitux previously was approved for treatment of colorectal cancer patients refractory to or intolerant of Pfizer's Camptosar (irinotecan). The per-unit cost of Erbitux could be modified if use is expanded to include treatment cycles of longer duration, ImClone says. The administration cycle for the head and neck cancer indication is eight weeks, in conjunction with radiation, and until progression/unacceptable toxicity for monotherapy, labeling states. Cetuximab currently is priced at about $19,000 for an eight-week cycle. The sBLA was filed Aug. 30 and received a priority review (1Pharmaceutical Approvals Monthly September 2005, In Brief)...

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