ALIMTA Receives Positive Opinion from CHMP

Eli Lilly and CompanyEli Lilly and Company (NYSE: LLY) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA® (pemetrexed for injection) as continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Positive opinions from the CHMP are reviewed by the European Commission, which then decides on whether to approve the indication in Europe.

Maintenance therapy is a relatively new concept in lung cancer treatment in which patients start maintenance therapy immediately following their first-line treatments to try to maintain disease control. No chemotherapy is currently approved in the "continuation maintenance" setting, in which one of the same medicines used in first-line treatment is continued as maintenance therapy. Currently approved maintenance therapies in lung cancer use different medicines in the first-line and maintenance phases of treatment.

"Lung cancer is one of the most difficult cancers to treat and new therapy options are much needed," said Allen Melemed, M.D., M.B.A., Alimta senior medical director with Lilly Oncology. "If approved, ALIMTA would be the first tailored treatment option based on efficacy that can potentially extend lives beginning in first-line treatment and continuing through maintenance in advanced nonsquamous non-small cell lung cancer."

The CHMP's opinion was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology Annual Meeting.(1) In this study, patients with advanced nonsquamous NSCLC received initial therapy with four cycles of ALIMTA plus cisplatin. Patients whose disease did not progress continued to the maintenance phase, where progression-free survival was assessed in patients who received ALTIMA plus best supportive care (BSC), compared with those who received placebo plus BSC.

In the EU and U.S., ALIMTA is already approved in the first-line, maintenance and second-line settings for treatment of patients with advanced nonsquamous NSCLC.

About Non-Small Cell Lung Cancer (NSCLC)
Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million cancer deaths annually.(2) About 85 - 90 percent of all lung cancers are NSCLC.(3) The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(4) as well as histologies classified as 'other.'

About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer. Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of 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.

1. Paz-Ares LG, De Marinis F, PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 29: 2011 (suppl; abstr CRA7510).
2. World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003,, (July 25, 2011).
3. American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 2010, American Cancer Society,, (July 25, 2011).
4. American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society,, (July 25, 2011)..