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 | | ALIMTA(R) (PEMETREXED FOR INJECTION) RECEIVES EUROPEAN APPROVAL FOR HISTOLOGICALLY-BASED USE IN FIRST-LINE TREATMENT OF MOST COMMON LUNG CANCER | | | Eli Lilly & Company | | 11/04/2008 | | | INDIANAPOLIS - Approval Marks Third European Indication for ALIMTA
Eli Lilly and Company (NYSE: LLY) today announced that 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), the most common form of lung cancer. This approval - the third for pemetrexed in Europe - follows an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on February 21, 2008.
The EMEA specifically approved pemetrexed in combination with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology. Histology is the microscopic study of tissue and NSCLC is classified by its histology. Previously, all histologies were treated similarly.
"This approval opens the door for a novel, tailored approach based on histology or tissue type," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. "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 evaluated pemetrexed plus cisplatin versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin. The 1,725-patient 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(1).
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.
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.
"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," said Dr.Scagliotti.
Data from the first-line NSCLC study was presented at the Presidential Symposium at the 12th World Conference on Lung Cancer (WCLC) in Seoul, Korea, on September 5, 2007, and at the Presidential Symposium III at the 14th Annual European Cancer Conference (ECCO) on September 24, 2007, in Barcelona, Spain.
This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the European Union, as well as Norway, Iceland, and Liechtenstein.
Pemetrexed as Second-Line NSCLC Treatment
In regard to the second-line indication for pemetrexed in NSCLC, the EMEA has approved a change in the indication to patients with other than predominantly squamous cell histology. This decision was based on a retrospective analysis of Phase III data in patients treated with either pemetrexed or docetaxel second-line that showed NSCLC patients with other than predominantly squamous cell histology had improved survival when treated with pemetrexed as compared to docetaxel, whereas patients with squamous cell histology treated with docetaxel had improved survival compared to pemetrexed. Data from this trial was presented at ECCO on September 25, 2007, in Barcelona(2). | |
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