Alimta™ Expanded Access Program

Eli Lilly and Company has an expanded access program with its drug Alimta™ (pemetrexed) for treatment of malignant pleural mesothelioma (MPM). The program, begun in July 2002, was developed with the Food and Drug Administration (FDA).It allows elegible patients-those who cannot have surgery but may have already received chemotherapy or radiation- to receive Alimta™ at no charge, through their oncologist. The "Open-Label Study" also involves collecting safety information about the drug from people enrolled in the program.

Expanded access programs make drugs still in research available as soon as possible for treating patients who have diseases for which there aren't other satisfactory therapies. Patients on such programs are given an agent that is not yet commercially available, although the sponsor is actively pursuing marketing approval through the FDA. The Alimta™ program is based on the FDA's preliminary review of results from clinical trials, including results from a Phase III trial presented at the 2002 and 2003 meetings of the American Society of Clinical Oncology (ASCO). Findings showed significant benefits for people treated with a combination of Alimta™ and cisplatin compared with those treated only with cisplatin. Lowered white blood cell counts were the most common side effect. People receiving Alimta also reported improved quality of life.

For more information about the Alimta™ expanded access program, see the study description on the Eli Lilly website and have your physician call 1-866-347-9503.