Merck: Erbitux Indication Extension Submitted for First-Line Advanced or Metastatic NSCLC in the EU

01-Apr-2011 - Germany

Merck KGaA announced that it has submitted an indication extension to the European Medicines Agency (EMA) for the approval of Erbitux® (cetuximab) in combination with standard first-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 FLEXa 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% (p=0.002).i Merck analyzed further clinical data for the submission and plans to present additional results at upcoming congresses.

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