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FDA approves Alimta as maintenance therapy for advanced lung cancer


ROCKVILLE, Md. The Food and Drug Administration has approved the first maintenance therapy for advanced lung cancer, the agency announced Monday.

The agency announced the approval of Eli Lilly & Co.’s Alimta (pemetrexed), an injected drug that works by disrupting the B-vitamin folate, which is needed for cell replication in patients with non-small cell lung cancer.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, director of the FDA’s Office of Oncology Products, in the Center for Drug Evaluation and Research. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles.”

Maintenance therapies are designed to prevent tumors from returning after they have been shrunk through chemotherapy.

The FDA originally approved the drug in 2004 as a treatment for the cancer mesothelioma.

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