The first and only drug regimen proven to help patients with an asbestos-related cancer live longer was approved by the US Food and Drug Administration (FDA).

Alimta, to be introduced shortly by Eli Lilly and Company, was approved for use with cisplatin, a standard chemotherapy agent, for the treatment of malignant pleural mesothelioma, a cancer of the lining of the lungs, in patients who are not candidates for surgery. Malignant pleural mesothelioma is "one of the most devastating kinds of cancer a person can have," said Paolo Paoletti, vice president of oncology clinical research at Lilly. "This is a cancer that is lethal, painful and debilitating."

Estimates are between 10,000 and 15,000 people worldwide are diagnosed annually with malignant pleural mesothelioma, a figure that is increasing. Most people do not learn they have malignant pleural mesothelioma until the disease has progressed to an advanced stage when treatment with surgery or radiation is not an option.

Alimta/cisplatin drug regimen was compared to cisplatin alone in a trial of 448 patients from 19 countries - the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival was increased 30 per cent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 per cent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 per cent treated with cisplatin alone1. Both the median and one-year rates of survival were of these findings were statistically significant.

"For the first time ever we have proof that a chemotherapeutic regimen helps patients with malignant pleural mesothelioma live longer -- that's a big deal," said Claude Denham, medical oncologist with Texas Oncology in Dallas. In addition, according to research findings, there was an improvement in lung function (forced vital capacity) on the Alimta/cisplatin arm compared to the cisplatin (or control) arm.2