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news.The European Committee for Medicinal Products for Human Use has recommended that European regulators approve Merck KGaA's application for the cancer drug Erbitux in head and neck cancer.
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Erbitux is currently licensed in the European Union for metastatic colorectal cancer after being first approved in Switzerland in December 2003. Germany’s Merck licensed the right to market Erbitux outside the US and Canada from New York-based ImClone Systems in 1998.
If approved by the European Commission for this expanded indication, Erbitux will be the first targeted cancer therapy available for the treatment of head and neck cancer in the EU.
The license extension endorses the use of Erbitux as a first-line treatment in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck.
“We believe that Erbitux is one of the most significant advances in the treatment of head and neck cancer in the last 30 years. It offers the potential for improved control and prolonged survival in this challenging disease. We are confident that the clear survival benefit demonstrated by Erbitux in head and neck cancer patients reinforces the potential of this medicine in other cancer types,” said Elmar Schnee, deputy member of the executive board of Business Sector Pharmaceuticals at Merck.