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New Erbitux data = new chance

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and ImClone "plan to discuss" the positive results of a Merck KGaA-sponsored study of Erbitux with FDA "as they relate to the U.S. filing for cetuximab in advanced colorectal cancer." FDA refused to file the BLA for the epidermal growth factor receptor antagonist in December 2001, and Bristol has projected a new BLA submission in 2004. Merck KGaA's Phase II study, presented at the American Society of Oncology annual meeting in Chicago June 1, compared cetuximab monotherapy and combination use with irinotecan in patients with irinotecan-refractory, EGFR-expressing colorectal cancer. Response rate was 22.9% for the combo vs. 10.8% for cetuximab-alone, median time to progression was 4.1 months vs. 1.5 months, overall rate of disease control was 55.5% vs. 32.4%, and median survival was 8.6 months vs. 6.9 months. The differences in response rate and time to progression were statistically significant, the companies report. Merck KGaA plans a mid-2003 European filing and a 2004 launch...
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