This approval – the third for pemetrexed in Europe – follows an initial positive opinion issued by the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on February 21, 2008. The EMEA specifically approved pemetrexed in combination with cisplatin as a first-line treatment for non-small-cell lung cancer (NSCLC) patients with other than predominantly squamous cell histology.
The approval in first-line NSCLC is based on a Phase III randomized study that evaluated pemetrexed plus cisplatin versus GEMZAR plus cisplatin. The 1,725-patient study, the largest Phase III clinical trial undertaken in the first-line setting of NSCLC, met its primary endpoint of non-inferiority relative to overall survival. This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the EU, as well as Norway, Iceland, and Liechtenstein.
Richard Gaynor, vice president of cancer research and global oncology platform at Lilly, said: “This approval opens the door for a novel, tailored approach based on histology or tissue type.”