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FDA Approves Sprycel for Chronic Myeloid Leukemia

Drug given accelerated approval to treat patients who have failed to respond to other therapies

THURSDAY, June 29 (HealthDay News) -- The U.S. Food and Drug Administration has approved an oral drug called Sprycel (dasatinib) for the treatment of patients with chronic myeloid leukemia who have failed treatment with Gleevec or other therapies. The drug was given accelerated approval for this indication, and was also approved for use in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have also failed to respond to other treatments.

"Although the long-term benefits of Sprycel in chronic myeloid leukemia are not yet known, early studies have suggested that Sprycel may offer a significant improvement for many patients whose disease is resistant to other therapies," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research, in a statement. "However, further data from ongoing studies are needed to evaluate whether Sprycel provides an actual clinical benefit in chronic myeloid leukemia."

The approval was based on several single-arm studies including 400 patients who had failed to respond to other therapies. In those trials, 45 percent of patients in the earliest stage, or chronic phase, of chronic myeloid leukemia had a response to the drug. About 31 to 59 percent of patients in later stages, or those with Ph+ALL, responded to the drug.

Sprycel, which is manufactured by Bristol-Myers Squibb, can cause anemia, neutropenia and thrombocytopenia, as well as fluid retention, bleeding, diarrhea and other side effects.

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