The European Commission has granted marketing authorization to extend the use of the targeted cancer therapy Erbitux (cetuximab) of Merck KGaA, in combination with radiotherapy, for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
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. Erbitux is already licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy, stated a company release.
Erbitux is the first targeted cancer therapy to be approved for the treatment of SCCHN and provides a much-needed new treatment option for this challenging and increasingly prevalent cancer type. The new indication granted by the European Medicines Agency (EMEA) approves Erbitux for use in combination with radiotherapy for locally advanced SCCHN, i.e. cancer that has not yet spread to other parts of the body. The marketing authorization is based on results of an international, randomized phase III study of 424 patients.
"Erbitux takes head and neck cancer treatment an enormous step forward, providing more patients with the potential for a long-term benefit or cure. We are conscious that these results open a new era in the management of locally advanced SCCHN," Dr. Wolfgang Wein, Merck Senior Vice President Global Oncology Commercialization said adding, "The approval of Erbitux across the EU for a second indication is a continuation of our commitment to ongoing research in the oncology field, with the aim of improving the health and quality of life for cancer patients."
"Head and neck cancer is an extremely challenging cancer type, with five-year survival rates typically low. The approval of Erbitux to treat head and neck cancer represents a major advancement to addressing an escalating unmet medical need," said Dr. James Bonner, University of Alabama, principal investigator for the study.
Erbitux was granted approval by SwissMedic in December 2005 for use in combination with radiotherapy in the treatment of patients with previously untreated advanced SCCHN. On March 1, 2006, the FDA 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. In Argentina, Erbitux is also approved as a single agent and in combination with radiotherapy. Erbitux continues to be studied as a first-line treatment in combination with platinum-based chemotherapy in recurrent or metastatic head and neck cancer (the EXTREME study), added the release.