European Medicines Agency (EMEA) Approves ALIMTA® (pemetrexed For Injection) For Use In Lung Cancer Treatment

On April 11, 2008, an announcement by Eli Lilly and Company (NYSE: LLY) indicated that European health authorities have 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 (NSCLC), the most common form of lung cancer. This is the third approval that pemetrexed has received in Europe, and it comes after the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion in mid-February. The act will allow all 27 countries of the European Union, Norway, Iceland, and Liechtenstein to use the therapy.

Richard Gaynor, M.D. (VP of cancer research and leader of Lilly's global oncology platform) said, "This approval opens the door for a novel, tailored approach based on histology or tissue type. 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."

Currently, more than 85 countries allow pemetrexed in combination with cisplatin to treat malignant pleural mesothelioma (MPM) when the disease is unresectable or when curative surgery is infeasible. Countries also allow pemetrexed to be used as a second-line, single agent treatment for patients with locally advanced or metastatic NSCLC after chemotherapy. This most recent approval allows the drug to be used as a first-line treatment for patients with NSCLC who have other than predominantly squamous cell histology.

More than 1 million people die from lung cancer every year, and 85 to 90 percent of all lung cancers are NSCLC. Categorized by five stages, NSCLC starts at stage 0 and rises to the level of severe at stage IV. The disease can spread through the lymphatic system, penetrating the chest lining, ribs, and the nerves and blood vessels that lead to the arm. If cancerous cells get into the bloodstream, additional potential targets include the liver, bones and brain.

The EMEA's approval is explicitly for pemetrexed combined with cisplatin as a first-line treatment for NSCLC patients who have a cell histology that is not predominantly squamous. NSCLC is categorized according to its histology (the microscopic study of tissue), and in the past all histologies were treated similarly.

This recent approval in first-line treatment of NSCLC is rooted on a Phase III randomized trial that compared pemetrexed plus cisplatin with GEMZAR® (gemcitabine HCl for injection) plus cisplatin. The phase III clinical trial, containing 1,725 patients, met its main endpoint of non-inferiority relative to overall survival.

When survival was analyzed by histology in a pre-planned histological analysis, participants that had either adenocarcinoma or large-cell carcinoma and were treated with the pemetrexed regimen in the first-line setting showed an improvement that was clinically relevant in overall survival. Patients with squamous cell histology, however, demonstrated better overall survival when treated with the gemcitabine regimen.

Lead investigator Giorgio Scagliotti, M.D. (Department of Clinical and Biological Sciences Thoracic Oncology Unit, University of Torino, Orbassano, Italy) stated that this approval is an important milestone in the quest to treat the cancer that is the leading cause of death in the world. He 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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