Eli Lilly files for Alimta approval in Europe
24 September 2007 00:00 in Pharmaceutical Company Product News
Eli Lilly has announced the submission of a centralised review application with the European Medicines Agency for Alimta (pemetrexed for injection) in combination with cisplatin as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC).
This application is based on clinical study results from a trial investigating the use of Alimta with cisplatin compared to Gemzar (gemcitabine HCl for injection) plus cisplatin which met its primary endpoint of the non-inferiority of Alimta and cisplatin.
At present, Alimta is approved in over 85 countries as a second-line single-agent treatment for locally advanced or metastatic NSCLC patients before chemotherapy.
The drug is also approved as a combination treatment with cisplatin in unresectable malignant pleural mesothelioma patients.
Richard Gaynor, vice-president of cancer research and global oncology platform leader for Lilly, said: "In this clinical study, Alimta plus cisplatin demonstrated similar efficacy to Gemzar plus cisplatin, a widely used regimen for first-line NSCLC, while providing a more favourable toxicity profile and greater convenience."
He added that the company is looking forward to the regulatory review of the compound, while noting the importance of offering clinicians a range of possible treatments for NSLCL.
Last month, the National Institute for Health and Clinical Excellence issued its final guidance on Alimta, ruling that the drug should not be used on the NHS as a treatment for locally advanced or metastatic NSCLC as it does not make the best use of resources on the health service.
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