Cetuximab's label expanded for use as monotherapy

October 5, 2007

Erbitux approved as single agent for metastatic colorectal cancer

A supplemental Biologics License Application (sBLA) has been approved for monoclonal antibody cetuximab (Erbitux, ImClone/Bristol-Myers Squibb). The therapy can now be used as a single agent in epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer (mCRC) in patients who have failed treatment with both irinotecan (Camptosar, Pfizer) and oxaliplatin (Eloxatin, Sanofi-Aventis). The approval was based on results of a large phase III trial that compared cetuximab and best supportive care (BSC) with BSC alone in 572 EGFR-positive patients. According to Bristol-Myers Squibb, cetuximab is the only approved biologic therapy that has demonstrated improved overall survival as a single agent in patients with mCRC. Cetuximab is also approved for treating mCRC in combination with irinotecan and for treatment of certain types of head and neck cancer.

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