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ImClone Systems and Bristol-Myers Squibb Update the Status of Non-Small Cell Lung Cancer Supplemental Biologics Application Submission for ERBITUX
Bristol Myers-Squibb Company, 01/26/09

ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company announced that the companies have decided, after discussion with the U.S. Food and Drug Administration (FDA), to withdraw, and eventually resubmit, the advanced non-small cell lung cancer (NSCLC) supplemental Biologics License Application (sBLA) for ERBITUX (cetuximab). This decision was based upon a Chemistry Manufacturing and Controls (CMC) matter with regard to the pre-clinical pharmacokinetic comparability of the U.S. marketed version of ERBITUX with the clinical supplies used by Merck KGaA.

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