Pfizer (PFE) Gets FDA Approval for BOSULIF as Ph+ CML Treatment

September 4, 2012 4:17 PM EDT
Pfizer Inc. (NYSE: PFE) announced today the U.S. Food and Drug Administration (FDA) has approved BOSULIF (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy. Patients in the registrational trial included patients who were previously treated with imatinib [GleevecĀ®] or imatinib plus at least one second generation tyrosine kinase inhibitor (TKI).1 Once daily BOSULIF represents the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second generation TKI.

Chronic myelogenous leukemia is one of the four most common types of leukemia, with more than 5,000 new cases diagnosed per year in the United States.2 Today, as many as 26,000 Americans are living with CML, a number that is expected to increase tenfold by 2040. While strides have been made in recent years, approximately one-third of patients receiving imatinib as initial therapy do not achieve an optimal response, and of those who ultimately require second generation TKIs, approximately half do not have a good outcome.

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