Merck KGaA has been boosted this morning by the news that regulators in Europe has approved Erbitux for first-line use in head and neck cancer.

Specifically, the firm’s Merck Serono division has received the thumbs-up from the European Commission to extend the use of Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The therapy was previously approved for use in combination with radiotherapy for locally advanced disease.

The European approval is based primarily upon the results of the EXTREME study, published in the New England Journal of Medicine in September 2008. The study revealed that patients treated with Erbitux plus chemotherapy experienced a median overall survival increase of nearly three months compared to chemotherapy alone, equating to a 20% reduction in the risk of death during the study period. The data also demonstrated a 70% rise in median progression-free survival and an 80% relative increase in response rate.

Wolfgang Wein, executive vice president of oncology at Merck Serono, said that this latest approval “is fantastic news” and “recognises the impressive potential of Erbitux to extend patients' lives”. It also confirms the high activity against difficult to treat cancers, he added.

Merck noted that there are around 143,000 cases of head and neck cancer in Europe, and more than 68,000 deaths due to the disease, each year. About 40% of those patients have recurrent and/or metastatic SCCHN.