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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-14
February 5, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Approves First Drug for Rare Type of Cancer

The Food and Drug Administration (FDA) today approved Alimta (pemetrexed disodium) for use in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma-a rare type of cancer. Alimta received a priority review and is designated as an orphan drug. It is the first drug approved for this condition.

Cancer of the mesothelium, a membrane that covers and protects most of the internal organs of the body is rare; about 2,000 new cases are diagnosed in the United States each year. This form of cancer is usually associated with a history of asbestos exposure. Asbestos fibers lodged in the lung attach to the outer lung lining and chest wall, causing tumors to grow. By the time symptoms appear, the disease is usually advanced, and patients live, on average, nine to thirteen months following diagnosis.

"Up to now there has been no effective treatment for treating mesothelioma. Alimta offers new promise in treating this fatal cancer," said FDA Commissioner Mark B. McClellan M.D., Ph.D, "and its quick approval demonstrates FDA's commitment to making safe and effective products available as soon as possible."

The effectiveness of Alimta was established in one randomized clinical trial comparing the effects of treatment with Alimta given with cisplatin to treatment with cisplatin alone. Patients receiving Alimta and cisplatin lived three months longer after randomization than patients given cisplatin alone (12 months vs. nine months). Alimta must be administered with vitamin B-12 and folic acid supplementation to decrease the incidence and severity of adverse effects.

The most common adverse reactions observed with use of Alimta are low white blood count, nausea, vomiting, fatigue, rash, and diarrhea. Patients and caregivers should be encouraged to report the onset of fever, chills, diarrhea, and mouth ulcers immediately, since these symptoms could be a sign of infection, resulting from bone marrow suppression by the drug. Orphan drugs are developed to treat rare diseases, that is, conditions that affect fewer than 200,000 people in the U.S. The Orphan Drug Act provides a seven-year period of exclusive marketing for the drug to the first sponsor who obtains marketing approval for a designated orphan drug.

Alimta will be distributed by Eli Lilly and Company, Indianapolis, Ind.

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