German drug maker Merck KGaA announced that biotechnology business unit MerckSerono received approval from the European Medicines Agency (EMEA) to market blockbuster cancer drug Erbitux (cetuximab) as firs-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease.

The EMEA approval was based in a study results of EXTREME published in the New England Journal of Medicine in September 2008. The study showed that adding Erbitux to standard chemotherapy significantly extended overall and progression-free survival.

Patients treated with Erbitux plus chemotherapy experienced the following improvements compared to chemotherapy alone:

* Median overall survival increase of nearly three months (10.1 vs. 7.4 months; p=0.04), equating to a 20 percent reduction in the risk of death (HR: 0.80) during the study period

* 70 percent increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)

* 80percent relative increase in response rate (36 percent  vs. 20 percent; p<0.001).

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 percent of patients with head and neck cancer have recurrent and/or metastatic.

Head and neck cancer is the sixth-most common cancer worldwide and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinuses, and other sites located in the head and neck area.
Erbitux is Merck KGaA second best selling drug with 645 million dollars over the first nine months of 2008.

Erbitux is marketed in the USA by Bristol-Myers Squibb and ImClone Systems its present owner and it is in the process of been taken over by Eli Lilly & Co.