Merck KGaA has submitted an application to regulators in Europe to expand the use of Erbitux for the first-line treatment of head and neck cancer.

The European Medicines Agency will now look at broadening the use of Erbitux (cetuximab) which is currently approved for the treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck in combination with platinum-based chemotherapy. The latest submission is based on data from the company’s EXTREME study which involved 442 patients with previously untreated recurrent and/or metastatic SCCHN who were treated with either Erbitux plus platinum-based chemotherapy or chemotherapy alone.

The study showed that the drug when added to platinum-based chemotherapy significantly increased overall survival, ie by 2.7 months. The findings from EXTREME were presented at the American Society of Clinical Oncology congress in June 2007.

Erbitux represents “a real breakthrough for the first-line treatment of head and neck cancer as it is the first treatment in more than 30 years to show a significant survival benefit,” said Wolfgang Wein, executive vice president of oncology at the firm’s Merck Serono unit”.

Merck is the European licensee for Erbitux, which was discovered by ImClone and is sold in the USA with partner Bristol-Myers Squibb.