CPMP recommends Erbitux approval
The Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Agency for the Evaluation of Medicinal Products (EMEA), has recommended full approval for Erbitux, opening the way for European approval of the drug in mid 2004.
The Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Agency for the Evaluation of Medicinal Products (EMEA), has recommended full approval for Erbitux, opening the way for European approval of the drug in mid 2004.
It was first launched in Switzerland in December 2003 for use in combination with irinotecan, and has since been approved in the US.
Erbitux is an IgG1 monoclonal antibody that specifically targets and blocks the epidermal growth factor receptor (EGFR), which is expressed in more than 80% of metastatic colorectal cancers. By blocking the EGFR, Erbitux also inhibits angiogenesis by reducing the production of the Vascular Endothelial Growth Factor (VEGF).
It is recommended in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy. The company licensed the right to market Erbitux outside the US and Canada from ImClone Systems in 1998. In Japan, Merck KgaA has co-exclusive marketing rights with ImClone Systems.
'With a substantial clinical programme already underway, we are working to assess the safety and efficacy of this compound in other types of cancers to help even more patients,' said Professor Bernhard Scheuble, ceo of Merck KgaA
In order to focus more of its resources on the core areas of oncology and cardiometabolic care, Merck will discontinue development of EMR 62203, the PDE V inhibitor intended to treat male erectile dysfunction. The compound was in Phase II clinical development.