ALIMTA(R) Recommended by Special Health Authority in United Kingdom

Eli Lilly and CompanyEli Lilly and Company (NYSE: LLY) announced that its chemotherapy ALIMTA(R) (pemetrexed for injection) received a positive "Final Appraisal Determination" from the United Kingdom's National Institute for Health and Clinical Excellence (NICE). Specifically, NICE's Final Appraisal Determination recommends ALIMTA as an option for the maintenance treatment of people with locally advanced or metastatic non-small cell lung cancer with other than predominantly squamous cell (nonsquamous) histology if disease has not progressed immediately following platinum-based chemotherapy first-line chemotherapy. This recommendation is the second step in a three-step approval process; NICE expects to issue its final guidance this summer.

ALIMTA was approved in July 2009 in the same setting by the European Commission. However, without a positive recommendation from NICE, patients struggle to get access under the UK's state funding agency, the National Health Service (NHS). NICE is a special health authority of the NHS.

The U.S. Food and Drug Administration (FDA) similarly approved ALIMTA in July 2009 for the treatment of patients with non-small cell lung cancer to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC, called squamous cell.

ALIMTA has previously received positive, final recommendations from NICE as a first-line treatment in combination with cisplatin for locally advanced and metastatic non-small cell lung cancer for patients with other than predominantly squamous cell (nonsquamous) histology, as well as a treatment for metastatic pleural mesothelioma, also used in combination with cisplatin.

"This decision is a promising step toward recognizing the value of ALIMTA for patients, payer organizations and doctors," said John H. Johnson, president of Lilly Oncology. "Most importantly, it means more advanced nonsquamous NSCLC patients may have access to treatment that can potentially prolong their lives."

Maintenance therapy represents a new approach in treating advanced nonsquamous NSCLC. Traditionally, patients who respond to first-line chemotherapy are monitored until the disease recurs and are then treated with a second-line regimen. In maintenance therapy, rather than halting further treatment until disease progression, patients who have disease control following first-line therapy are treated immediately with a maintenance regimen.

The NICE recommendation for ALIMTA was based on data that demonstrated it improved overall survival for advanced nonsquamous NSCLC cancer patients in the maintenance setting. The appraisal committee concluded that the evidence submitted fulfilled the end of life criteria.

Overall survival data for ALIMTA as a maintenance therapy for NSCLC was presented on May 31, 2009 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). The global, multicenter, double-blind Phase III trial compared efficacy with respect to overall survival of ALIMTA plus best supportive care versus placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy. ALIMTA was not included among the induction regimens studied in the maintenance trial. Myelosuppresion is usually the dose-limiting toxicity with ALIMTA therapy.

Patients in the trial were treated with ALIMTA (500 mg/m2 on day one of each 21-day cycle) plus best supportive care or placebo plus best supportive care. All patients were supplemented with vitamin B12, folic acid and dexamethasone.

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