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Erbitux approved for head and neck cancer in Europe

The European Commission has granted marketing authorization to extend the use of the targeted cancer therapy Erbitux (cetuximab).

April 5, 2006

Merck KgaA's targeted cancer therapy Erbitux (cetuximab) is to be used in combination with radiotherapy, for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN), heralds hope for head and neck cancer patients in Europe, the release said.

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.

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. For patients treated with Erbitux combined with radiotherapy, median survival significantly improved by nearly 20 months (49.0 months versus 29.3 months) and the duration of locoregional control (ie time from treatment start to spread of the tumor beyond the head and neck) improved by 9.5 months (24.4 versus 14.9 months) compared to radiotherapy alone. 

The most commonly reported side effect with Erbitux is an acne-like skin rash which is generally manageable and has been associated with a good response to therapy in a number of tumor types. Erbitux does not significantly increase typical radiotherapy related side effects, in particular mucositis, in the treatment of locally advanced squamous cell carcinoma of the head and neck. 

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.(5) 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). 

Every year in Europe, around 100,800 people are diagnosed with head and neck cancer and almost 40,000 die from the disease. Head and neck cancer is the sixth-most frequently occurring cancer worldwide. Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90 percent of head and neck cancers are of the squamous cell variety and more than 90 percent of these express EGFR, which is critical for tumor growth. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is often particularly challenging to treat since most patients present with advanced disease, have secondary tumors and suffer from other co-morbidities.

Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately five percent of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. 

Erbitux has already obtained market authorization to treat colorectal cancer in 53 countries: Switzerland, the US, Mexico, Argentina, Chile, Iceland, Norway, the European Union, Peru, Australia, Croatia, Israel, Bulgaria, Panama, Guatemala, Colombia, Singapore, Hong Kong, South Korea, Canada, Ecuador, Malaysia, the Philippines, Taiwan, China, India, Lebanon, Venezuela and Nicaragua for the use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the US, Argentina, Chile, Mexico, Peru, Singapore, Australia, Panama, Colombia, Guatemala, Hong Kong, Canada, Ecuador, the Philippines, Lebanon, Venezuela and Nicaragua Erbitux is also approved for single-agent use.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Switzerland, Argentina and Colombia. In Argentina Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy. In March 2006, FDA granted approval for both indications in the U.S. 

Merck KGaA, Darmstadt, Germany, licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems.

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