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Erbitux gets European approval for head and neck cancer

ImClone Systems has said that its European development and marketing partner Merck KGaA has received approval from the European Commission for the anticancer drug Erbitux to be used in the expanded indication of head and neck cancer.

Erbitux is already licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy.

With the European Commission’s approval, Erbitux will be available for the treatment of head and neck cancer in all 25 member states of the European Union as well as Iceland and Norway in accordance with local legal regulations.

The license application is based on the results from a randomized, international phase III trial conducted by ImClone Systems and Merck KGaA, which examined the impact of combining Erbitux with radiation on overall survival and locoregional control in 424 patients with locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).

“The approval of Erbitux by the European Commission is a significant advancement for patients with head and neck cancer,” stated Joseph Fischer, Interim CEO of ImClone Systems. “Designed to inhibit the function of the epidermal growth factor receptor (EGFR), Erbitux is the first and only monoclonal antibody approved for head and neck cancer.”

The FDA recently approved Erbitux for use in combination with radiotherapy for the treatment of locally or regionally advanced SCCHN and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed.