FDA Approves Alimta-Cisplatin Combination for Treatment of Asbestos-Related Cancer Mesothelioma

The first and only drug regimen proven to help patients with an asbestos-related cancer live longer was approved today by the U.S. Food and Drug Administration (FDA).

Alimta® , to be introduced shortly by Eli Lilly and Company (NYSE: LLY), was approved for use with cisplatin, a standard chemotherapy agent, for the treatment of malignant pleural mesothelioma, a cancer of the lining of the lungs, in patients who are not candidates for surgery. Malignant pleural mesothelioma is "one of the most devastating kinds of cancer a person can have," said Paolo Paoletti, M.D., vice president of oncology clinical research at Lilly. "This is a cancer that is lethal, painful and debilitating."

Estimates are between 10,000 and 15,000 people worldwide are diagnosed annually with malignant pleural mesothelioma, a figure that is increasing. Most people do not learn they have malignant pleural mesothelioma until the disease has progressed to an advanced stage when treatment with surgery or radiation is not an option.

Finding an active drug treatment has proved long and difficult. "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," said Nicholas Vogelzang, M.D., who led the global Phase III clinical trial evaluating Alimta/cisplatin while director of the University of Chicago Cancer Research Center. (On Jan. 2, 2004, Vogelzang became director of the Nevada Cancer Institute in Las Vegas.)

Alimta/cisplatin proved different. This drug regimen was compared to cisplatin alone in a trial of 448 patients from 19 countries - the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival was increased 30 percent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 percent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 percent treated with cisplatin alone. Both the median and one-year rates of survival were of these findings were statistically significant.

"For the first time ever we have proof that a chemotherapeutic regimen helps patients with malignant pleural mesothelioma live longer -- that's a big deal," said Claude Denham, M.D. a study co-investigator for U.S. Oncology and a medical oncologist with Texas Oncology in Dallas. In addition, according to research findings, there was an improvement in lung function (forced vital capacity) on the Alimta/cisplatin arm compared to the cisplatin (or control) arm.

Important Safety Information

The hematolgoic and non-hematologic side effects associated with Alimta are neutropenia, thrombocytopenia, anemia, nausea, vomiting, fatigue, diarrhea, skin rash and pain. To reduce the severity of treatment-related toxicities, all patients on Alimta must receive daily doses of folic acid and intramuscular injections of vitamin B12.

As with many chemotherapies, the dose-limiting toxicity of Alimta is usually myelosuppression. Specific dose-modification may be required for patients who experience grade 3 or 4 toxicities. Patients with kidney impairment should not receive Alimta therapy. Patients should also inform their doctors if they are taking NSAIDs like ibuprofen. It is recommended that frequent blood tests be performed on all patients receiving Alimta.

Additional Regulatory Milestones

In Europe, Lilly has completed its submissions for the use of Alimta, with cisplatin in the treatment of malignant pleural mesothelioma and single-agent Alimta in the second-line treatment of non-small cell lung cancer. Lilly has also recently submitted a New Drug Application to the FDA for the use of single-agent Alimta in the treatment of second-line non-small cell lung cancer.