ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company have decided, after discussion with the US 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 US marketed version of Erbitux with the clinical supplies used by Merck KGaA (ImClone's partner for Erbitux outside of North America).

It is important to note that the discussions with FDA do not have any impact on currently-marketed Erbitux, including the safety and efficacy of the product for approved indications.

Erbitux (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumour cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1).