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NEJM Editorial Dubs Gleevec the Gold Standard Treatment for Chronic Myeloid Leukemia

   Portland, Ore.

Head-to-head study with interferon shows Gleevec has greater efficacy, less toxicity in newly diagnosed patients

Gleevec is the new "gold standard" for treatment of chronic myeloid leukemia (CML), according to an editorial published in the March 13 issue of the New England Journal of Medicine (NEJM). The editorial cites a study published in the same issue that proves Gleevec superior to interferon in the treatment of patients newly diagnosed with CML. The NEJM is the first journal to provide new CML treatment standards that include Gleevec.

The study of Gleevec and interferon showed remarkably greater response and less toxicity from Gleevec in patients newly diagnosed with CML. This is the first time the study has been published in a peer-reviewed journal. Until this study, interferon was viewed as the best treatment for CML. Now Gleevec is recommended instead as first-line therapy for CML.

CML is one of four common types of leukemia, affecting about 5,000 Americans each year. The Food and Drug Administration (FDA) approved Gleevec in May 2001.

Brian Druker, M.D., the senior author of the study, is JELD-WEN Chair of Leukemia Research at Oregon Health & Science University Cancer Institute and a Howard Hughes Medical Investigator.

"This is great news for patients with this type of leukemia because not only is Gleevec FDA-approved, but doctors now have scientific evidence that this is an effective and safe treatment," Druker said. "This clearly establishes Gleevec as the gold standard of care for CML."

The study tracked 1,106 newly diagnosed CML patients at 177 centers in 16 countries who were either given Gleevec or interferon. After 18 months approximately 87 percent of the Gleevec patients experienced a major cytogenetic response (meaning a reduction of leukemia cells in their blood), compared with 34 percent of patients on interferon. Approximately 76 percent of Gleevec patients achieved a complete cytogenetic response (no leukemia cells present) compared with about 15 percent of patients on interferon. Also, only about 3 percent of Gleevec patients saw their disease progress, compared with 9 percent of patients treated with interferon. Finally, less than 1 percent of Gleevec patients were taken off the study due to intolerance, compared with 25 percent of the interferon patients.

Interferon, a naturally occurring hormone that must be injected by patients each day of treatment, generally keeps the worst symptoms of CML at bay, but is not a cure for most patients and carries many side effects. In contrast, Gleevec, a pill taken once a day, has few side effects and reduces or eliminates signs of the disease for most CML patients when treated early.

Druker, in collaboration with scientists at Novartis, helped develop Gleevec to target the molecular cause of CML. In 2001 the FDA broke a record for cancer therapy approval by fast-tracking Gleevec and approving it in less than three months for patients who failed interferon treatment. The FDA also approved Gleevec as an effective treatment for gastrointestinal stromal tumors in 2002, a deadly form of intestinal cancer that, until then, had been difficult to treat.

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