ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has notified ImClone Systems that it has accepted for filing and review the Company's Biologics License Application (BLA) for the use of Erbitux (cetuximab) in combination with irinotecan for the treatment of patients with EGFR-expressing irinotecan-refractory metastatic colorectal cancer. The Companies previously announced that ImClone Systems had filed the BLA on August 14, 2003. The Companies also announced today that, as requested, the application will be reviewed for accelerated approval and has been granted priority review designation by the FDA. Based on the priority review designation, the FDA has six months from the submission date, or until February 13, 2004 to take action on the BLA filing.
Erbitux is an investigational IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. Erbitux is designed to bind to EGFR and prevent natural ligands called growth factors from binding to the receptor and inducing phosphorylation, i.e., activation of signaling to the tumor. Erbitux is also being studied in second-line colorectal cancer, and other types of cancer that express the EGF receptor, including lung, pancreatic, ovarian and head and neck cancers. The most common adverse events reported in clinical trials of Erbitux have been an acne-like rash, asthenia, diarrhea, nausea, abdominal pain and vomiting. Severe allergic reactions were observed in a small percentage of patients.