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5-year study shows Gleevec's potency against chronic myeloid leukemia

In a study of patients with chronic myeloid leukemia, some 95 percent have survived the cancer after five years due to treatment with Gleevec, according to results published this week in the New England Journal of Medicine.

Howard Hughes Medical Institute investigator Brian Druker, who led the five-year study, said the findings demonstrate Gleevec's effectiveness against the formerly fatal disease. He noted that the study's results emphasize the value of the new approach to developing cancer drugs that target the specific genetic malfunctions that drive cancer.

Druker, who is at the Oregon Health & Science University Cancer Institute, led an international group of 31 co-authors who published their findings in the December 7, 2006, New England Journal of Medicine.

Druker also led the original clinical development of Gleevec, which inhibits a biological switch called a tyrosine kinase that is abnormally activated in CML. This activation, triggered by an abnormal breakage and rearrangement of a chromosome, drives uncontrolled proliferation of white blood cells. CML is a relatively rare disorder that affects about 5,000 people a year in the United States. Gleevec, marketed by Novartis, is the trade name under which the drug imatinib is sold.

The five-year study followed 553 patients, all of whom were receiving Gleevec as their primary therapy. The study had begun as a comparative study of patients given Gleevec or the previous standard treatment, interferon alfa plus cytarabine. However, the superiority of Gleevec led the researchers to change the study into a long-term assessment of Gleevec's efficacy. The major finding of the study was that only five percent of the patients died from CML during the five-year period, with 11 percent dying from all causes.

The report shows that the drug produced few significant side effects. "The issue of side effects is an important one, because patients with CML need to remain on
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Contact: Jennifer Michalowski
michalow@hhmi.org
301-215-8576
Howard Hughes Medical Institute
6-Dec-2006


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