European regulators have given the green light to Eli Lilly's Alimta for a histologically-based use in the first-line treatment of advanced non-small-cell lung cancer.

The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use which specifically approved Alimta (pemetrexed)with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology. This represents the third European approval for the drug.

Richard Gaynor, vice president of cancer research at Lilly, said that this latest approval "opens the door for a novel, tailored approach based on histology or tissue type". He added that "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 1,725-patient randomised study that examined pemetrexed plus cisplatin versus Gemzar (gemcitabine) plus cisplatin. The lead investigator of the study, Giorgio Scagliotti, of the University of Torino in Italy, said the data "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".

This latest approval will help boost sales of Alimta which enjoyed fourth-quarter 2007 sales of $244.1 million, a jump of 42% compared with the year-ago period.