Bristol-Myers Squibb leukemia drug wins FDA approval

[Guest guest]

Bristol-Myers Squibb leukemia drug wins FDA approval

ASSOCIATED PRESS

2:28 p.m. June 28, 2006

WASHINGTON – 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.

On the Net:

Food and Drug Administration: www.fda.gov/

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