Eli Lilly and Company announced 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 (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 US 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 US, 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. About 85 to 90 per cent of all lung cancers are NSCLC. 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 for more than half of all NSCLC diagnoses, as well as histologies classified as 'other'.

"This recommendation from the CHMP is encouraging," said Richard Gaynor, vice president of cancer research and global oncology platform leader for Lilly. "It brings us one step closer to offering a tailored treatment option that can potentially extend lives for non-small cell lung cancer patients with nonsquamous histology."

The EU submission is based on data from a phase-III trial in which patients received pemetrexed or placebo to evaluate the overall survival benefit of pemetrexed in the maintenance NSCLC setting. This is the third trial to demonstrate that histology can be used to tailor treatment with other than predominantly squamous NSCLC. Full data from this trial are due to be presented at the forthcoming 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held in Orlando, Florida from 29 May to 2 June 2009.