NEW YORK--(BUSINESS WIRE)--ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today 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 (ImClone’s partner for ERBITUX outside of North America).
