European Medicines Agency (EMEA) Approves ALIMTA ® (pemetrexed for injection) for use in the treatment of lung cancer

EMEA approval is explicitly pemetrexed in combination with cisplatin as first-line treatment for patients with NSCLC who have a biopsy of cells that are not predominantly squamous cell. NSCLC is classified by its histology (microscopic study of tissues), and in the past, all histologies were treated similarly.The principal investigator Giorgio Scagliotti, MD (Department of Biological Sciences and Clinical Thoracic Oncology Unit, University of Torino, Orbassano, Italy) said that the approval is a milestone in research for the treatment of cancer is the leading cause of death in the world. He said: “This study provides further evidence of the need to use a tailored approach for the treatment of patients with lung cancer, rather than simply using a particular drug because of the treatment phase.”

Over 1 million people die of lung cancer each year, and 85 to 90 percent of all lung cancers are NSCLC. [3, 5], divided into five stages, NSCLC stage starts at 0 and rises to the level of stage IV severe. [4] The disease can spread through the lymphatic system, penetrating the chest wall, ribs, and the nerves and blood vessels that lead to the arm. If cancer cells enter the bloodstream, to other potential targets include the liver, bones and brain.

See complete Warnings, Precautions, Adverse Effects, and DOSAGE AND ADMINISTRATION in full prescribing information accompanying safety and dosage.

ALIMTA is contra-indicated in patients with a history of severe hypersensitivity reaction to pemetrexed or to any other ingredient used in the formulation.

ALIMTA should not be administered to patients with creatinine clearance of 25% of patients, were AST elevation (72 vs 52, 78), increased alkaline phosphatase (71 vs 64, 77), anemia (65 vs 45, 73): elevated ALT (72 vs 38, 72), leukopenia (71 vs 15, 64), pain (10 vs 7, nausea and vomiting (64 against 58, 71) and neutropenia (62 versus 18, 61), thrombocytopenia (47 vs 15, 36), 42), fever (30 vs 16, 38), proteinuria (10 vs 2, 32), constipation (10 vs 11, 31), diarrhea (24 vs 31, 30), rash (24 vs 13, 28), and bilirubin elevation (16 vs 25, 26).

This press release contains forward-looking statements about the potential of ALIMTA and GEMZAR for the treatment of metastatic non-small current beliefs and reflects Lilly. However, as with any pharmaceutical under development, there are risks and uncertainties in the process of development, marketing, and regulatory review. There is no guarantee that the product will receive regulatory approvals. There is also no guarantee that the product will continue to be a commercial success. For details on these risks and uncertainties, see Lilly’s filings with the U.S. Securities and Exchange Commission. Lilly undertakes no obligation to update these forward-looking statements.

[4] American Cancer Society, “How non-small cell lung cancer staged?” www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Small_Cell_Lung_Cancer_ October 15, 2007, American Cancer Society, Staged.asp? RNAV = cry (February 21, 2008).

Richard Gaynor, MD (vice-president of cancer research and global platform leader for Lilly Oncology), said: “This approval opens the door to a novel, personalized approach based on histology or tissue. Our hope is that this study provides physicians with a powerful tool for choosing the right drug to the right patient that leads to optimal therapeutic results. ”

Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.

Lilly, a leading company focused on innovation, developing a growing portfolio of first-class pharmaceutical products best-in-class, applying the latest research in its laboratories around the world and from collaborations with eminent scientists organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers – through medicines and information – for some of the most urgent medical needs worldwide.

Currently, more than 85 countries allow pemetrexed in combination with cisplatin for the treatment of malignant pleural mesothelioma (MPM) when the disease is unresectable or when curative surgery is impossible. The countries that also allow for the use of pemetrexed as second-line monotherapy in patients with locally advanced or metastatic NSCLC after chemotherapy. This new approval allows the drug to be used as first-line treatment for patients with NSCLC who have different especially squamous cell histology.

[1] Scagliotti G, Purvish P, et al. Phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in patients never treated with chemotherapy for lung cell locally advanced or metastatic non-small cell lung cancer (NSCLC). Abstract PRS-3, 12th World Conference on Lung Cancer (WCLC) 2007. Journal of Thoracic Oncology, Vol 2 No 8, Supplement 4, Page S306, August 2007.

The recent approval in the first-line treatment of NSCLC is anchored on a randomized phase III trial of pemetrexed plus cisplatin compared with Gemzar ® (gemcitabine HCl for injection) plus cisplatin. The clinical trial phase III, which contains 1725 patients met the primary endpoint of non-inferiority in overall survival. [1].

When survival was analyzed by histological analysis in a pre-planned histological, participants who had either adenocarcinoma or large cell carcinoma were treated with diet and pemetrexed in first-line therapy showed an improvement that was clinically significant survival overall. Patients with squamous cell carcinoma, however, showed better overall survival when treated with gemcitabine.

[3] American Cancer Society, “What non-small cell lung cancer?” October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/ _Lung_Cancer.asp CRI_2_4_1x_What_Is_Non-Small_Cell? RNAV = cry (February 21, 2008).

[5] World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/lungcancerlow. pdf.

On 11 April 2008, an announcement by Eli Lilly and Company (NYSE: LLY) said that the European health authorities have approved the use of ALIMTA ® (pemetrexed for injection) for a histologically-based use for first-line treatment advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer. This is the third that pemetrexed has received approval in Europe, and it comes after the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in mid-February. The law will allow all 27 EU countries, Norway, Iceland, Liechtenstein and the use of therapy.

[2] Peterson P, Park K, et al. Pemetrexed is more effective in patients with non-squamous histology? A retrospective analysis of a Phase III study of pemetrexed vs docetaxel in previously treated patients with locally advanced non-small cell lung cancer (NSCLC). Abstract P # 6521, 2007 European Cancer Conference (ECCO 14). European Journal of Cancer Supplements, Vol 5, No 4, page 363.

For over four decades, Lilly Oncology collaborates with researchers from the choices of treatment for cancer and useful programs for patients and their physicians. Inspired by courageous patients living with cancer, Lilly Oncology provides treatments that are considered global standards of care and develop a broad portfolio of new therapies to accelerate the pace and progress of cancer treatments.

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