FDA: Pfizer Will Pull Ineffective Leukemia Drug
WASHINGTON (AP) - Federal health regulators say Pfizer has agreed to pull a leukemia drug off the market after a follow-up study showed it failed to slow the disease.
The Food and Drug Administration cleared the drug Mylotarg in 2000 under its accelerated approval program, which grants speedy access to drugs that show early promise. The drug was approved for patients older than 60 with acute myeloid leukemia, a bone marrow cancer.
However, the FDA says a follow-up study of the drug showed no increase in survival time when the drug is added to standard chemotherapy. In fact, more patients taking Mylotarg died compared with those taking chemotherapy alone.
The FDA says the drug will not be available to new patients.
(Copyright 2010 by The Associated Press. All Rights Reserved.)
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