European health authorities have approved the use of ALIMTA(R) (pemetrexed for injection) for a histologically-based use in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), Eli Lilly and Company has said.
The move follows positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).
The EMEA specifically approved pemetrexed with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology.
Richard Gaynor, from Lilly said: "This approval opens the door for a novel, tailored approach based on histology or tissue type.
"Our hope is that this study provides physicians with a powerful tool for choosing the right drug for the right patient that leads to optimal treatment results."
The approval in first-line NSCLC is based on a Phase III randomized study that examined pemetrexed plus cisplatin versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin.
The lead investigator of the study, Giorgio Scagliotti, M.D., Department of Clinical and Biological Sciences Thoracic Oncology Unit, University of Torino, Orbassano, Italy, said the approval of pemetrexed plus cisplatin in a first-line setting marked an important step forward in treating the world's leading cause of cancer deaths.
He said: "This study provides further evidence of the need to use a tailored approach to treating lung cancer patients, rather than simply using a particular medicine because of the treatment stage."