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A New Cancer-Fighting Role for Gleevec

Government OKs anti-leukemia drug to fight abdominal cancer

FRIDAY, Feb. 1, 2002 (HealthDayNews) -- Is Gleevec the "magic bullet" against cancer? It may be too soon to call the anti-leukemia drug the next Salk vaccine, but its outreach against other forms of malignancy is growing.

The U.S. Food and Drug Administration has approved Gleevec (imatinib mesylate) as a treatment against gastrointestinal stromal tumor (GIST). GIST attacks only about 5,000 people in the United States, and it grows in the stomach or intestines. It also metastasizes on or in the abdomen or the pelvis. It's hard to treat, because GIST is often inoperable.

In its "Talk Paper," the FDA explained how effective Gleevec was in combatting GIST: "In the study that was the basis for Gleevec's approval for treatment of GIST, 147 patients with unresectable (i.e., cannot be surgically removed) or metastatic GIST received daily oral Gleevec treatment," the FDA said. "While no patient had complete disappearance of cancer, 56 patients (38 percent) had reduction in tumor size by 50 percent or greater (partial response). Patients have not been followed long enough to determine the duration of the responses."

Gleevec's effectiveness in fighting chronic myelogenous leukemia was more dramatic. The drug was rushed through the approval process in May 2001 after two clinical trials showed almost complete disappearance of symptoms in 85 out of 86 adult patients.

The National Cancer Institute reported part of the results this way: "They [the researchers] reported that Gleevec restored normal blood counts in 53 out of 54 chemotherapy-resistant CML patients [in the second clinical trial], a response rate rarely seen in cancer with a single agent. Fifty-one of these patients were still doing well after a year on the medicine, and most reported few side effects."

Here is a question- and-answer page from the National Cancer Institute on the leukemia trials.

And here is the FDA Talk Paper that explains the latest approval.

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