ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that the Companies met with the U.S. Food and Drug Administration (FDA) to discuss clinical trial data including the Merck KGaA-sponsored 007 Phase II clinical trial of the investigational drug Erbitux (cetuximab) in patients with metastatic colorectal cancer as well as data from completed ImClone Systems-sponsored clinical studies. Based on the outcome of this meeting, ImClone Systems intends to submit a Biologics License Application (BLA) to the FDA in the second half of 2003, for approval of Erbitux for the treatment of metastatic colorectal cancer.
The 007 study was a randomized, two-arm, multi-center Phase II trial evaluating Erbitux monotherapy and the combination of Erbitux and irinotecan in 329 patients with irinotecan-refractory, EGFR-expressing colorectal cancer. The 007 study was presented June 1, 2003 at the American Society of Clinical Oncology annual meeting in Chicago, Illinois.
Erbitux is an investigational IgG1 monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. Erbitux was designed to bind to EGFR and help prevent natural ligands called growth factors from binding to the receptor and inducing phosphorylation, i.e., activation of signaling to the tumor. The most common drug-related adverse events reported in clinical trials of Erbitux have been an acne-like rash and asthenia. Severe allergic reactions may occur in a small percentage of patients.