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ALIMTA(R) (pemetrexed for injection) Receives Positive Opinion From CHMP as Maintenance Therapy for Nonsquamous Non-Small Cell Lung Cancer
Date:5/29/2009

INDIANAPOLIS, May 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA(R) (pemetrexed for injection) as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Following a positive opinion by the CHMP, any potential approval in the European Union (EU) is usually granted by the European Commission (EC) within two months. Lilly has also filed for approval of pemetrexed in the same indication with the U.S. Food and Drug Administration (FDA).

Should the EC approve the use of pemetrexed as maintenance treatment for NSCLC, it would mark the first chemotherapy approved for this indication. In the EU and U.S., pemetrexed is already approved, in combination with cisplatin, as a first-line treatment for locally-advanced or metastatic nonsquamous NSCLC for patients, and it is indicated as a single agent for the second-line treatment of patients with locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy. Pemetrexed also is indicated, in combination with cisplatin, for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million deaths annually.(1) About 85 - 90 percent of all lung cancers are NSCLC.(2) NSCLC 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 f
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