Erbitux cetuximab regulatory update

Merck withdrew an MAA to extend the label for Erbitux cetuximab to include first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high EGFR-expression in combination with platinum-based chemotherapy. The pharma said it withdrew the application based on feedback from EMA indicating that additional data would be required. Merck, which submitted the MAA last March, could not be reached for details on its plans for Erbitux in the indication. In 2009, CHMP issued and then confirmed a negative opinion against expanding Erbitux's label to include the indication (see BioCentury, Dec. 7, 2009). ...