ALIMTA^®/Cisplatin Approved to Treat Pleural Mesothelioma

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FDA Approves Sale of Mesothelioma Drug ALIMTA^®

February 13, 2004 — The Federal Drug Administration (FDA) has approved the drug ALIMTA^® (pemetrexed disodium) for use with a standard chemotherapy agent, cisplatin, to treat patients with pleural mesothelioma, a rare, aggressive cancer caused by exposure to asbestos. Although the ALIMTA^®/cisplatin combination does not cure the disease, it can prolong life and improve the lung function of mesothelioma patients, according to prior research.

The first and only drug specifically approved by the FDA to treat mesothelioma, ALIMTA^® works by blocking the enzymes necessary for cancer cells to synthesize thymidine and purine. The more traditional chemotherapy agent, cisplatin, is a platinum compound used in the battle against various types of cancer. ALIMTA^®/cisplatin is recommended for pleural mesothelioma patients who cannot undergo surgery because their cancer is too advanced. (See the discussion of extrapleural pneumectomy, a radical surgery that removes portions of the lung, the lining of the lung, and the diaphragm).

ALIMTA^® Clinical Trial Shows Drug’s Value in Mesothelioma Treatment

In a clinical trial published last year, the median survival time for those taking the ALIMTA^®/cisplatin combination was 12.1 months, as compared to 9.3 months for those taking only cisplatin. The one–year survival rate was 56.5 percent among pleural mesothelioma patients receiving ALIMTA^® plus cisplatin versus a 41.9 percent rate for patients receiving cisplatin alone. Also, the combination of ALIMTA^®/cisplatin was more effective in reducing pain and shortness of breath than cisplatin alone. Side–effects of ALIMTA^® included decreases in white blood cells, skin rashes, vomiting and fatigue. These were reduced by giving patients supplements of folic acid and vitamin B12.

“Throughout the 1970s, ’80s and really the ’90s, we tried a host of different drugs. I was involved in many of these trials and most of them had virtually no effect on the cancer [mesothelioma],” said Nicholas Vogelzang, M.D., who headed the clinical trial that finally led to the ALIMTA^® breakthrough for pleural mesothelioma patients. “For the first time ever we have proof that a chemotherapeutic regimen helps patients with malignant pleural mesothelioma live longer…” said Claude Denham, M.D., an ALIMTA^® study investigator for U.S. Oncology and a physician with Texas Oncology in Dallas (News Release, Eli Lilly, February 5, 2004).

History of ALIMTA^®

Because the results of clinical trials with ALIMTA^® were so promising, the FDA had made the drug available on a “compassionate use basis.” This meant that patients who had not yet received mesothelioma treatment were eligible to obtain ALIMTA^® free of charge before the FDA completed its formal drug review. Over one thousand mesothelioma patients received the drug in this way, according to its manufacturer, Eli Lilly.

ALIMTA^®/cisplatin is now available to pleural mesothelioma patients in the United States who cannot safely undergo surgery. Eli Lilly has also applied for permission to distribute ALIMTA^® in Europe.

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