Agent Now Available to Medically Eligible Patients With Malignant Pleural Mesothelioma

SOURCE: Eli Lilly and Company

Lilly Given OK To Make Alimta Available on Expanded Access Basis

INDIANAPOLIS--(BW HealthWire)--July 9, 2002--Eli Lilly and Company and the U.S. Food and Drug Administration have reached agreement to make Alimta ® (pemetrexed) available on an expanded access, or compassionate use, basis to medically eligible patients with malignant pleural mesothelioma, a devastating cancer usually associated with exposure to asbestos.

"What this essentially means is that qualified patients who have been diagnosed with malignant pleural mesothelioma and have not yet received treatment may be eligible to receive Alimta before, rather than after, the FDA review process," said Alan K. Hatfield, M.D., medical director, oncology, for Lilly's U.S. affiliate.

Expanded access programs are designed to make investigational agents available at the earliest opportunity for the treatment of patients with diseases for which no comparable or satisfactory alternative drug or other therapy is available. Under such programs, patients are given access to an agent that is not yet commercially available, although the sponsor is actively pursuing marketing approval.

Lilly is pursuing approval of Alimta in combination with cisplatin for the treatment of malignant pleural mesothelioma (MPM). In this disease, tumors grow in the linings of the lung, or pleura, and slowly suffocate the patient. By the time symptoms appear, the disease has usually progressed and patients live, on average, six to nine months following diagnosis. In addition to being characterized by a high mortality rate, MPM exacts an enormous physical toll -- severe, dense throbbing chest pain and chronic shortness of breath are hallmarks of this disease.

The FDA agreed to the expanded access program for Alimta based on a preliminary review of results from clinical trials. Included in this review were the results of a Phase III trial presented May 20 at the annual meeting of the American Society of Clinical Oncology. Findings showed that 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. In this trial, the most common side effect associated with Alimta and cisplatin was a decrease in infection-fighting white blood cells (technically known as neutropenia).

Under the expanded access program, Alimta will be available free of charge to patients with MPM who meet medical eligibility criteria.

"This is simply the right thing to do," said Paolo Paoletti, M.D., leader of the Alimta product team at Lilly. "The expanded access program provides hope for patients who are battling a devastating disease. It's clear to anyone who studies mesothelioma, or suffers from it, that patients and their families are in desperate need of treatment options."

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 on this trial can be found at www.ClinicalTrials.gov, a service of the National Institutes of Health.