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An Advancement for Leukemia Drug

Gleevec OKd for 'first-line' treatment

THURSDAY, Dec. 26, 2002 (HealthDayNews) -- Gleevec, a drug that showed significant results in combating a rare and mostly fatal type of leukemia, has passed another hurdle.

The U.S. Food and Drug Administration has announced that Gleevec (imatinib mesylate) has been approved for the "first-line treatment of patients with chronic myeloid leukemia (CML), an uncommon life-threatening form of cancer -- affecting about 40,000 people in the United States."

First-line treatment means that Gleevec can be administered after CML has been diagnosed. The drug was originally approved in 2001 under the FDA's accelerated approval regulations.The federal agency believed more time was needed to determine whether Gleevec would continue to be as effective in arresting the leukemia as it had been when it was used after other drugs had been tried.

"Today's (Dec. 20) approval represents continued efforts by government and industry to provide patients suffering from CML with additional therapies that have proven safe and effective through on-going research and clinical trials," said FDA Commissioner Dr. Mark B. McClellan. "With this new use, even more patients will have access to this product earlier on in their fight against cancer," he said in an FDA press release.

Approval was based on a clinical trial of 1,106 patients with newly diagnosed chronic phase CML, according to the FDA. Half were given Gleevec and half were given a standard drug therapy. The results: The patients treated with Gleevec after one year had significantly fewer cancerous cells in their blood and bone marrow. The rate of progression of disease was also decreased in the patients treated with Gleevec, according to the FDA.

Here is the FDA Talk Paper on the expanded use of Gleevec.

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