Bosulif Approved for Rare Leukemia

WEDNESDAY Sept. 5, 2012 -- Bosulif (bosutinib) has been approved by the U.S. Food and Drug Administration to treat chronic myelogenous leukemia (CML), a cancer of the blood and bone marrow that primarily affects older people, the agency said in a news release.

Some 5,430 people are expected to be diagnosed this year with the disease, which primarily is caused by a genetic mutation called the Philadelphia chromosome, the FDA said. This abnormality causes a person's bone marrow to produce an enzyme that triggers development of abnormal white blood cells known as granulocytes. The new drug works to block the effects of this enzyme.

Bosulif was evaluated in a clinical trial that included 546 adults with CML. The drug's most common side effects included diarrhea, nausea, low blood platelets, abdominal pain, rash, anemia, fever and fatigue.

The drug is marketed by Pfizer, based in New York City.

More information

To learn more about this approval, visit the FDA.

Posted: September 2012


View comments

Hide
(web1)