EMEA clears histology-based use for Alimta

US drug major Eli Lilly says that the European drug regulator has approved the use of Alimta (pemetrexed for injection) for a histologically-based use in the first-line treatment of advanced non-small-cell lung cancer, the most common form of lung cancer. This approval - the third for the agent in Europe - follows an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) earlier this year (Marketletter March 3).

The EMEA specifically approved Alimta in combination with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology. "This approval opens the door for a novel, tailored approach based on histology or tissue type," said Richard Gaynor, vice president of cancer research and global oncology platform leader for Lilly.

The first-line NSCLC clearance is based on Phase III study data that evaluated pemetrexed plus cisplatin versus Gemzar (gemcitabine HCl for injection) plus cisplatin. The 1,725-patient study, the largest Phase III clinical trial undertaken in first-line NSCLC, met its primary endpoint of non-inferiority relative to overall survival. However, when it came to survival by histology, the study found that Alimta patients with adenocarcinoma or large-cell carcinoma had a clinically-relevant improvement in overall survival in the first-line setting. In comparison, those with squamous cell histology had a more favorable overall survival on the gemcitabine regimen.