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Lilly Receives Fourth FDA Approval for ALIMTA(R) (pemetrexed for injection)
Date:7/6/2009

INDIANAPOLIS, July 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today it received a fourth approval from the U.S. Food and Drug Administration (FDA) for ALIMTA(R) (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.(1),(2) It is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(3) as well as histologies classified as "other."

"This FDA approval is encouraging news for non-small cell lung cancer patients, their caregivers and doctors," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. "It represents an important paradigm shift for NSCLC treatment - maintenance therapy as a way of extending survival in nonsquamous patients, using histology as a way of determining which NSCLC patients may benefit and which may not.

"Previously, patients received best supportive care following their chemotherapy. Now physicians and patients have a new option to improve survival," added Gaynor.

The notion of maintenance therapy in NSCLC is new. Maintenance therapy is treatment given after initial chemotherapy but before new tumor growth. And while pathologists routinely determine the cancer's histology,
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