ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company (BMS) received a complete response letter from the US Food and Drug Administration (FDA) for the first-line squamous cell carcinoma of the head and neck (SCCHN) supplemental Biologics License Application (sBLA) for Erbitux (cetuximab). The sBLA was accepted for filing and granted a priority review status in October 2008.

In its complete response letter, the FDA requested an additional pharmacokinetic study to confirm the comparability of Erbitux used in the first-line head and neck submission as compared to Erbitux currently marketed in the United States. Clinical supplies used in this sBLA were provided by Merck KGaA (ImClone's partner for Erbitux outside of North America).

As previously announced, ImClone Systems and Bristol-Myers Squibb recently withdrew the advanced non-small cell lung cancer sBLA for Erbitux because of the same matter. In both cases, the companies continue to work with the FDA to confirm pharmacokinetic comparability.

The companies' discussions with the FDA do not have any impact on currently-marketed Erbitux, including the safety and efficacy of the product for approved indications. Commercial supply for currently-marketed Erbitux is provided by ImClone.

In head and neck cancer, Erbitux is approved by the FDA to treat locally or regionally advanced SCCHN in combination with radiation therapy, and as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. In colorectal cancer (CRC), Erbitux is approved by the FDA as: a single agent for the treatment of EGFR-expressing metastatic CRC after failure of both irinotecan- and oxaliplatin-based regimens; a single agent for the treatment of EGFR-expressing metastatic CRC in patients who are intolerant to irinotecan-based regimens; and in combination with irinotecan for the treatment of EGFR-expressing metastatic CRC in patients who are refractory to irinotecan-based chemotherapy. The effectiveness of Erbitux in combination with irinotecan is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal carcinoma.

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).