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Bristol/ImClone Erbitux lung cancer plans

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb/ImClone will pursue accelerated approval of their EGFR antagonist Erbitux (cetuximab) for second-line treatment of non-small cell lung cancer under a special protocol assessment with FDA. Initiation of a Phase III study using tumor response rate as the primary endpoint was announced Oct. 7; 800 patients will be randomized to docetaxel or pemetrexed alone or in combination with Erbitux. Another Phase III study in first-line NSCLC is underway abroad with survival as the primary endpoint. The 1,100-patient study will compare platinum-based chemo and vinorelbine alone or in combination with Erbitux. The firms plan to conduct two supportive first-line trials, looking at response rate, with chemo regimens common in the U.S. "These three clinical trials could allow the companies to seek an indication in first-line treatment with platinum-based chemotherapy," ImClone notes...

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