Merck submits Erbitux indication extension to EMA for NSCLC treatment

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has submitted an indication extension to the European Medicines Agency (EMA) for the approval of Erbitux^® (cetuximab) in combination with standard 1st line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.

The submission is based on a new biomarker analysis of EGFR expression levels in tumors of patients participating in the Phase III FLEX study. New data, presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology in December 2010, showed that, among patients with high EGFR expression, the response rate was significantly increased by the addition of Erbitux to standard chemotherapy from 28.1% to 44.4%>1 Merck Serono analyzed further clinical data for the submission and plans to present additional results at upcoming congresses.

In Europe, lung cancer is the leading cause of death from cancer, accounting for 20% of all cancer deaths (28% in men and 10% in women). NSCLC accounts for approximately 80% of all lung cancer cases. At diagnosis, most patients with NSCLC present with advanced, non-operable (also called unresectable) disease, which is associated with a very poor prognosis. NSCLC remains difficult to treat with very few new effective drugs identified over the last ten years. The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.