Drug Company Agressively Pursues FDA Approval For New Mesothelioma Medicine

By Shannon Dininny, Associated Press

INDIANAPOLIS - Eli Lilly and Co. is working with U.S. regulators to speed up review of a drug to treat a rare cancer linked to asbestos exposure.

If approved, the drug, known as Alimta, would become the first medicine sanctioned by the U.S. Food and Drug Administration specifically to treat mesothelioma. The deadly tumors of the lungs or stomach are resistant to treatment and the cancer is nearly always fatal.

Alimta could hold promise for thousands of workers in the construction and shipbuilding trades worldwide who handled asbestos and could contract mesothelioma. Lilly is seeking a priority review by the FDA, meaning the regulator would review the drug within six months. A standard review takes 10 months.

Results of final clinical trials for the drug released May 20 showed patients receiving the drug, chemotherapy medicine and vitamins lived 13 months after being diagnosed with pleural mesothelioma. That compared with seven months for those who received only the standard chemotherapy drug Cisplatin and vitamins.

Patients taking the drug during the yearlong study of 456 people also suffered less pain and had fewer breathing difficulties, Lilly reported.

Lilly plans to submit the drug for approval in the United States and Europe next year, but already has arranged with the FDA to begin offering compassionate use of the drug to people diagnosed with the disease but not receiving treatment, company spokeswoman Judy Kay Moore said.

The company declined to release projected sales figures for Alimta, but Moore said Lilly also planned to test the drug on cancers of the stomach, colon, pancreas, breast and lung.

"When it shows activity in a hard-to-beat cancer, it almost definitely will in other types of cancers," she said.

Mesothelioma results in tumors, usually caused by asbestos fibers lodged in the lung, which attach to the lung lining and chest wall. Over time, tumors squeeze and compress the lungs, making it difficult and painful to breathe.