Eli Lilly and Company's anti-cancer drug Alimta received its second US approval in 2004. The US FDA granted accelerated approval for Alimta for the treatment of locally advanced or metastatic non-small cell lung cancer in previously treated patients. In February, Alimta was approved, in combination with cisplatin (a common chemotherapy agent), for the treatment of malignant pleural mesothelioma, a cancer often associated with asbestos exposure, an official release said.

The FDA accelerated approval is based on Alimta's efficacy and safety profile as evidenced in one of the largest Phase III studies to date in the second-line setting that compared Alimta directly to Taxotere. In July, the study was the basis for a unanimous recommendation for accelerated approval by the FDA's Oncologic Drug Advisory Committee.

Alimta's approval was based on the drug's ability to reduce tumour size (response rate) in advanced non-small cell lung cancer patients.

The FDA also cited Alimta's significantly improved safety profile as compared to Taxotere as a supporting basis for approval. Patients on Alimta also experienced less Grade 3 or 4 neutropenia (a decrease in infection-fighting white blood cell counts); less neutropenia with fever; less diarrhoea; fewer hospitalizations due to adverse events and less hair loss. As with all chemotherapy agents, patients on Alimta and Taxotere experienced low-blood cell counts. Patients treated with Alimta experienced higher rates of Grade 3 or 4 Alanine Transaminase (ALT), a laboratory measurement of liver function. Some of the most common Grade 3 or 4 toxicities associated with Alimta (regardless of causality) include anaemia (8 per cent vs. 7 per cent for Taxotere); fatigue (16 percent vs. 17 per cent for Taxotere); anorexia (5 per cent vs. 8 per cent for Taxotere); and infection without neutropenia (6 per cent vs. 4 per cent for Taxotere).

"Alimta's development is a demonstration of our commitment to patients with cancer and is testament to our emergence as a leader in oncology," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "With the advances we are making - and will continue to make - via our existing and future oncology products, we are confident that Lilly will emerge as one of the premier oncology companies in the world," said Sidney.

Alimta is an antifolate that simultaneously blocks three separate enzyme targets vital to the survival of cancer cells. Alimta's administration includes vitamin supplementation with folic acid and vitamin B12. A team of researchers led by Lilly discovered that this vitamin regimen significantly reduces the drug's side effects without negatively impacting its ability to kill cancer cells. The administration cycle for Alimta is a 10-minute infusion, once every three weeks.

"Alimta represents a medical advance in the treatment of lung cancer," Paul Bunn, director of the University of Colorado Cancer Centre said adding, "The benefits Alimta offers patients are clear, and it is much better tolerated than the current standard, and is conveniently administered."

Paolo Paoletti, vice president of oncology clinical research at Lilly said, "Alimta represents a true breakthrough in cancer care and is pushing the boundaries of conventional therapies by demonstrating a good response rate, while maintaining reduced toxicity via vitamin supplementation."

In accordance with the FDA's accelerated approval, Lilly will continue to gather data for Alimta in non-small cell cancer.

In February, Alimta, with cisplatin, was approved by the FDA for the treatment of malignant pleural mesothelioma, a cancer associated with asbestos exposure.