FDA OKs Bristol-Myers Squibb Leukemia Drug

A Bristol-Myers Squibb Co. drug received accelerated federal approval Wednesday to treat some leukemias where other drugs have failed.

The drug dasatinib, being sold under the brand-name Sprycel, won Food and Drug Administration approval to treat all phases of chronic myeloid leukemia in patients with either resistance or intolerance to the drug Gleevec. Gleevec, made by Novartis AG, is used when standard interferon-alpha therapy has failed.

Chronic myeloid leukemia accounts for 14 percent of adult leukemia cases, according to the FDA.

Bristol-Myers also received full approval to sell Sprycel to treat Philadelphia chromosome-positive acute lymphoblastic leukemia, again in cases where patients show resistance or intolerance to other treatments.

Major safety issues with the Bristol-Myers drug include suppression of the bone marrow's ability to make blood cells, fluid retention, hemorrhage and an increased risk of arrhythmia, according to the FDA.

Also, the cancer drug can harm fetuses and is not to be used by pregnant women.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

Bristol-Myers Squibb Co.: http://www.bms.com/