New Leukemia Drug Gets FDA Nod
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.
The most common side effects of Bosulif are diarrhea, nausea, low blood platelet levels, vomiting, abdominal pain, rash, anemia, fever, and fatigue.