The EMEA submission is based on a study which evaluated Alimta plus cisplatin versus Gemzar (gemcitabine HCl for injection) plus cisplatin. The study met its primary endpoint of non-inferiority relative to overall survival in a first-line non-small cell lung cancer (NSCLC) setting.
Richard Gaynor, vice president of cancer research and global oncology platform leader for Lilly said: “In this clinical study, Alimta plus cisplatin demonstrated similar efficacy to Gemzar plus cisplatin, a widely used regimen for first-line NSCLC, while providing a more favorable toxicity profile and greater convenience. We look forward to the outcome of the EMEA review.”