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FDA Approves New Drug for CMLSTI 571, also called Gleevec™, received approval from the US Food and Drug Administration (FDA) on May 10, 2001 for the treatment of chronic myelogenous leukemia (CML). The drug has been approved for use with patients in the chronic phase of CML who are no longer responding to interferon therapy, in the accelerated phase of CML or in myeloid blast crisis. The drug received expedited FDA approval after two reports in the April 5, 2001 edition of the New England Journal of Medicine documented a dramatic response to the drug by a test group of CML patients. Fifty-three of 54 patients in the chronic phase of CML experienced a complete disappearance of leukemic cells, usually within a month of taking daily doses of 300 mg or more of the drug, and more than half the group had a decrease in the number of bone marrow cells with genetic abnormality that is characteristic of the disease (the Philadelphia chromosome). The drug was also given to patients with a more advanced form of CML (myeloid blast crisis)—a stage at which patients often have only a few months to live. Twenty-one out of 38 patients experienced a decrease in leukemic cells, and in four patients, the blood counts completely returned to normal. All but one of the patients subsequently relapsed. Although Gleevec™ has generated much excitement, stem cell transplantation is still the only known cure for CML now. Several questions remain to be answered about the new drug including how long Gleevec™ will control CML, whether the drug actually cures patients of CML, and what effect the use of Gleevec™ will have on the likelihood of a successful transplant for patients who relapse after taking the drug. Several clinical trials to further test the effectiveness of Gleevec™ alone, or in combination with other drugs, are planned or underway. For information about these trials phone the National Cancer Institute at 1-800-422-6237 or visit http://cancertrials.nci.nih.gov. |
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