First Drug for Advanced Lung Cancer Earns FDA Approvals

Alimta, the first drug for maintenance therapy of advanced or metastatic lung cancer, has been approved by the Food and Drug Administration.

The drug, made by Eli Lilly & Co. and known generically as pemetrexed, may prevent the form of lung cancer from progressing further after the size of the tumor has shrunk or been stabilized following chemotherapy, the FDA said. Alimta works by disrupting metabolic processes which depend on the B-vitamin folate for cell replication.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Alimta was approved in 2004 for treatment of mesothelioma, a cancer caused by exposure to toxic asbestos, and later approved for treating non-small cell lung cancers in patients whose conditions worsened before chemotherapy. The drug also was previously approved for initial treatment of advanced non-small cell lung cancer.

Study Finds Benefits

A study of Alimta found the drug improved survival rates of some patients who took it for maintenance therapy, according to the FDA. In that study, 600 patients with various types of non-small lung cancer survived an average of 15.5 months after chemotherapy compared to just 10.3 months for patients who were given inactive placebo pills instead of Alimta.

All patients who participated in the study also received standard medical care in additional to Alimta, officials said.

However, patients with predominately squamous cell cancer did not benefit from treatment with Alimta in the study, the FDA said.

Side effects of Alimta include fatigue, nausea, loss of appetite, numbness or a tingling sensation in the hands and feet, skin rash, and damage to blood cells.

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