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news.Merck KGaA has submitted an application with the Japanese Pharmaceuticals and Medical Devices Agency for the use of Erbitux in treating patients with advanced colorectal cancer.
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The filing in Japan is a result of a development collaboration between ImClone Systems, Bristol-Myers Squibb, and Merck KGaA. Merck licensed the drug from ImClone Systems.
The Japanese submission was based on results from studies conducted in Europe and Japan which confirm the activity of Erbitux in patients with metastatic colorectal cancer. In Japan, the incidence of colorectal cancer has increased markedly during the last 50 years.
Erbitux is the first IgG1 monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR) to be submitted for marketing authorization in Japan.
In vitro assays and in vivo animal studies have shown that the binding of Erbitux to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.