Merck Serono, a division of Merck KGaA, Darmstadt, has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the 1st-line treatment of patients with non-small cell lung cancer (NSCLC). Taking the opinion seriously Merck Serono will work closely with the CHMP to unravel the value of Erbitux for patients benefit most.

Merck Serono's decision to request re-examination follows consultation with key stakeholders in the NSCLC treatment community, coupled with its confidence in the clinical data supporting Erbitux in this potential indication.

Based on the phase-III study FLEX Erbitux has been acknowledged in the oncology academic community. The data from the FLEX study were presented in the plenary session 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. 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'.

In the randomized, multinational, phase-III FLEXa study, the overall survival was significantly prolonged for patients receiving Erbitux in 1st-line therapy.

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