Eli Lilly and Company's chemotherapy agent, Alimta (pemetrexed) has been granted marketing authorization by the European Commission (EC) for two distinct cancer indications. This regulatory first for Lilly means that Alimta can be offered to two patient groups each battling devastating forms of cancer. The product launch and availability of Alimta will vary in each European Member State.

Alimta, in combination with cisplatin, now becomes the first and only approved chemotherapy in the European Union to help patients with malignant pleural mesothelioma live longer. Alimta, given as a single agent, is also an important new second-line treatment for patients suffering from non-small cell lung cancer, Lilly said in a release.

"Alimta represents a true breakthrough in cancer care pushing the boundaries of conventional therapies with an innovative scientific approach. Alimta provides efficacy and when given with folic acid and B12 offers controlled side effects. Vitamin supplementation helps patients remain healthy enough to complete the full-recommended course of therapy - increasing the opportunity Alimta has to work," said Christian Manegold, professor at Ruprecht-Karls-University and a consultant in Hematology/Oncology for the Thoracic Hospital in Heidelberg, Germany. "By providing a balance of proven efficacy and controlled side effects, Alimta will help positively change the way chemotherapy is perceived," he added.

Cytotoxic chemotherapy, which kills cells to combat cancer, has been the foundation of advanced cancer therapy for decades. Alimta, a cytotoxic chemotherapy, is a novel multi-targeting antifolate that simultaneously blocks at least three separate enzymes essential to the survival of cancer cells. A team of researchers led by Lilly discovered that vitamin supplementation of folic acid and B12 given with Alimta significantly reduces the frequency and severity of the drug's side effects without compromising its ability to kill cancer cells.

Apart from this approval, Alimta was also approved as a single agent therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after previous chemotherapy. The administration for Alimta is a convenient 10-minute infusion, once every three weeks.

"We are extremely pleased by the European Commission's approval of Alimta in Europe. This is an historical day - two patient groups benefit from today's approval," Edmundo Muniz, oncology platform team leader at Lilly said adding, "We now have a very strong non-small cell lung cancer franchise led by Gemzar in the first-line metastatic setting and Alimta in the second-line metastatic setting. Oncology is an area of tremendous unmet medical need, and we are committed to being a leader in developing new therapies for patients."

Clinical research of Alimta is ongoing in first-line non-small cell lung cancer, and in small cell lung, breast, colon, ovarian and gastric cancers and in combination with radiation.

The now approved combination of Alimta and cisplatin was compared to cisplatin alone in a clinical trial of 448 patients from 19 countries - the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival increased 30 per cent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 per cent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 per cent treated with cisplatin alone.

Malignant pleural mesothelioma is a rare cancer of the lining of the lungs. The disease is often associated with asbestos exposure and has a long latency period - usually between 20 and 40 years. Most people are not diagnosed until the cancer is in advanced stages and treatment with surgery or radiation is not an option. It is estimated that between 10,000 and 15,000 people around the world are diagnosed annually with malignant pleural mesothelioma.