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2/5/2004

FDA Approves Mesothelioma Treatment

Kate Traynor

The Food and Drug Administration (FDA) today approved the marketing of pemetrexed for the treatment of patients with malignant pleural mesothelioma who are not candidates for resection or curative surgery.

The product, which will be sold as Alimta, is to be used in combination with cisplatin. Eli Lilly and Company did not provide a specific launch date for pemetrexed but announced that it will be available soon.

According to FDA, mesothelioma is a rare disease, with about 2,000 new cases detected each year, most of them related to exposure to asbestos fibers. The regulatory agency has designated pemetrexed an orphan product because it treats a condition affecting fewer than 200,000 people in this country.

FDA approved pemetrexed on the basis of a single clinical trial showing that half of the patients treated with pemetrexed and cisplatin were still alive 12 months after enrolling in the study, compared with 9 months for patients who received cisplatin alone.

According to the product's FDA-approved labeling, pemetrexed is delivered by intravenous infusion at a recommended dosage of 500 mg per square meter of body surface area over 10 minutes on the first day of each 21-day treatment cycle. The recommended dosage of cisplatin is 75 mg per square meter of body surface area over two hours, beginning 30 minutes after the pemetrexed infusion ends.

The product's instructions for patients and caregivers recommend that, to reduce the toxic effects of pemetrexed, patients take 350-1,000 mcg of folic acid per day for five of the seven days before starting pemetrexed therapy and continue the supplementation daily throughout treatment and for 21 days afterward. Patients also require a vitamin B12 injection during the week before pemetrexed treatment begins and about every 9 weeks during therapy.

The most common adverse events associated with pemetrexed therapy are low red-blood-cell, white-blood-cell, or pletelet counts, fever, infection, sores on the mouth, throat or lips, and skin rashes. According to the labeling for pemetrexed, pretreatment with dexamethasone or an equivalent corticosteroid can reduce the frequency and severity of skin reactions to pemetrexed.

Patients undergoing pemetrexed therapy require periodic complete blood cell and platelet counts and kidney and liver function tests. Pemetrexed dosages should be reduced in response to certain laboratory test findings and toxicities.

Pemetrexed therapy is not recommended for patients with impaired kidney function.

Pemetrexed is supplied as 500 mg of lyophilized powder in sterile single-use vials.