INDIANAPOLIS, IN, February 5, 2004 -- 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.
Alimta® ("uh-LIMB-ta"), 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 advanced stages 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 Comprehensive Cancer Center. On Jan. 2, 2004, Dr. 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 mesothelioma cancer. 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 alone1. Both the median and one-year rate of survival 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 US Oncology and a medical oncologist with Texas Oncology in Dallas. In addition, according to research findings, there was animprovement in lung function (forced vital capacity) on the Alimta®/cisplatin arm compared to the cisplatin (or control) arm.2
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.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
This press release contains forward-looking statements, which involve risks and uncertainties. Actual results could differ materially. There can be no assurance that commercial use or future clinical trials will confirm the medical results referred to in this release, or that the product will prove to be commercially successful. Additional risks and uncertainties are described more fully in Exhibit 99 to Lilly's most recently filed Form 10-Q dated November 2003.
For full prescribing information, visit http://www.Alimta.com/
Alimta® (pemetrexed, Lilly)
1 Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21:2636-2644, 2003
2 Pistolesi M, Symanowski J, Gatzemeier U, et al. Improving pulmonary function in patients with malignant pleural mesothelioma: results from the phase III trial of pemetrexed + cisplatin vs. cisplatin. Lung Cancer 41:(Suppl 2) S220 (abstr P-513)
Eli Lilly and Company