ALIMTA^® Availability for Pleural Mesothelioma Patients

Mesothelioma News

FDA Allows Expanded Use of ALIMTA^® for Pleural Mesothelioma Patients

July 23, 2002 — The U.S. Food and Drug Administration (FDA) has agreed to allow the drug manufacturer, Eli Lilly, to make ALIMTA^® (pemetrexed) available on a “compassionate or expanded use basis” to pleural mesothelioma patients before it becomes commercially available. This means that pleural mesothelioma patients who have not yet received treatment may be eligible to receive ALIMTA^® free of charge before the FDA review process is completed.

ALIMTA^® is a drug that inhibits enzymes necessary for the synthesis of thymidine and purine. It has shown activity against tumors in lung, breast, colorectal, and gastric cancers as well as against tumors due to mesothelioma. Lilly seeks approval of ALIMTA^® for pleural mesothelioma treatment when the drug is taken in combination with cisplatin, a platinum–containing chemotherapy drug.

The FDA based its expanded use decision on recent clinical trials in which mesothelioma patients were treated with ALIMTA^®. In one such study, patients treated with a combination of ALIMTA^® and cisplatin survived longer and experienced less pain and shortness of breath than those treated with cisplatin alone. The most common side effect associated with the ALIMTA^®/cisplatin combination was a decrease in infection–fighting white blood cells (technically known as neutropenia). Patients received folic acid and vitamin B12 supplements to minimize toxicity. Another earlier study showed some therapeutic promise for mesothelioma patients who took ALIMTA^® and B vitamins alone without other cancer–fighting drugs.

For more information on the expanded access program, physicians may call 1–866–347–9503 (patients are asked to work through their physicians). Additionally, information can be found at the clinical trials web site of the National Institutes of Health (search on ALIMTA^®).