Erbitux cetuximab regulatory update

FDA issued a complete response letter for an application seeking to expand Erbitux cetuximab's label to include first-line non-small cell lung cancer (NSCLC). Eli Lilly and partner Bristol-Myers do not plan to resubmit the application, which was based on data from the Phase III FLEX trial showing that Erbitux plus vinorelbine and cisplatin improved overall survival (OS) by 11.3 months vs. 10.1 months for chemotherapy alone (p<0.0441) (see BioCentury, June 9, 2008). Lilly said FDA asked for an additional clinical trial showing an improvement in OS, as well as a validated diagnostic for a biomarker to predict patient response to Erbitux.

Last year, Merck submitted an application to EMA to extend the indication for Erbitux to include first-line treatment of patients with advanced or metastatic NSCLC with high EGFR-expression in combination with platinum-based chemotherapy (see BioCentury, April 4, 2011). The pharma said a CHMP opinion is expected next half. ...