Merck Serono, a division of Merck KGaA, announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), to extend the use of the targeted therapy Erbitux (cetuximab) to include 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The submission to the EMEA was supported by the results of the EXTREME study - ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer - which was published recently in the renowned New England Journal of Medicine. The study investigated the efficacy of Erbitux in combination with platinum-based chemotherapy in 1st-line treatment of recurrent and/or metastatic SCCHN.

The EXTREME study demonstrated that adding Erbitux to platinum-based chemotherapy significantly prolongs patients' lives. Overall survival time increased from 7.4 to 10.1 months when Erbitux was added to standard platinum-based chemotherapy. This is the first regimen to show a survival benefit in 30 years.

"The positive opinion we received for Erbitux in the 1st-line treatment of recurrent and/or metastatic SCCHN is very good news. It draws us closer to obtaining approval and advancing the broader use and patient benefit of Erbitux across various tumor types. SCCHN is typically a difficult cancer to treat and Erbitux will provide the only advance in treatment options in 30 years for this patient population," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono.

Erbitux is already approved in combination with radiotherapy for locally advanced disease. The results of the EXTREME study supported the application to extend the Erbitux label in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. The application was submitted in June 2008.

In Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease, each year. About 40 per cent of patients with head and neck cancer have recurrent and/or metastatic SCCHN. Head and neck cancer is the sixth most frequently occurring cancer worldwide and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90 per cent of head and neck cancers are of the squamous cell variety and nearly all express the epidermal growth factor receptor (EGFR), which is critical for tumour growth.6 Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have secondary tumours, in addition to suffering from other co-morbidities. At least 75 per cent of all head and neck cancers are attributed to its two major risk factors, smoking and alcohol consumption.

Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group.