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European health authorities have approved the use of Alimtra (pemetrexed for injection) for a histologically-based treatment in advanced non-small-cell lung cancer.
Eli Lilly and Company announced the approval which comes after a positive response from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP).
The EMEA specifically approved pemetrexed in combination with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology.
The approval follows a Phase III randomised study that studied pemetrexed plus cisplatin versus GEMZAR (gemcitabine HCl for injection) plus cisplatin.
The 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.
However, when it came to survival by histology, the study found, in a pre-planned histological analysis, that patients with either adenocarcinoma or large-cell carcinoma had a clinically relevant improvement in overall survival when treated with the pemetrexed regimen in the first-line setting.
In comparison, patients with squamous cell histology were found to have a more favorable overall survival when treated with the gemcitabine regimen.
Lead investigator of the study, Giorgio Scagliotti, 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.”
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