The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC). Merck Serono, a division of Merck KGaA, is evaluating potential appeal options requesting that the CHMP re-examine data demonstrating clinical relevant benefits to patients.

Merck Serono respects the decision and will work closely with the CHMP to find ways to make Erbitux available to lung cancer patients. The company is convinced Erbitux will play a major role in NSCLC as it is the first and only compound in clinical development in more than 10 years to increase overall survival in a patient population including all histologies.

Erbitux has generated great interest in the oncology community based on the phase-III study FLEX which showed a significant survival advantage: The data from the FLEX study were highlighted as one of the three most important results presented during the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) - the worldwide leading cancer congress; The Journal of Clinical Oncology named Erbitux as one of the major research advances in this difficult-to-treat cancer; In addition, Erbitux is already recommended for the 1st-line therapy of NSCLC by US Clinical Practice Guidelines issued by the independent National Comprehensive Cancer Network (NCCN); A recent publication in one of the leading medical journals in Europe, The Lancet, concludes that Erbitux 'added to platinum-based chemotherapy can be regarded as a new standard 1st-line treatment option for patients with EGFR-expressing advanced non-small-cell lung cancer'.

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