From Our 2012 Archives
New Leukemia Drug Bosulif Approved for Chronic Myelogenous Leukemia
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FDA Approval of Pfizer's Bosulif for the Treatment of Chronic Myelogenous Leukemia (CML)
By Daniel J. DeNoon
Reviewed by Louise Chang, MD
Sept. 7, 2012 -- The FDA has approved Pfizer's Bosulif for the treatment of chronic myelogenous leukemia (CML) for people who do not respond to or who cannot tolerate other treatments.
CML is a relatively rare disease. It strikes about 5,400 people a year. Most people have a rare mutation, dubbed the Philadelphia mutation, which causes the bone marrow to make too much tyrosine kinase enzyme. Bosulif inhibits this enzyme.
Other drugs approved for CML -- Gleevec and Tasigna from Novartis and Sprycel from Bristol-Myers Squibb -- inhibit tyrosine kinase in other ways.
"With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease," said Richard Pazdur, MD, director of the FDA's office of hematology and oncology products, said in a news release.
In clinical trials, 55% of CML patients previously treated with Gleevec or other drugs had a return to normal blood counts with no sign of leukemia within the first 48 weeks of treatment with Bosulif.
SOURCE: News release, FDA.