FDA nod for Pfizer's rare leukemia drug Bosulif

In a third cancer drug approval in just over a year for drugs behemoth Pfizer (NYSE: PFE), the US Food and Drug Administration has approved the company’s 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 [Gleevec from Novartis] or imatinib plus at least one second generation tyrosine kinase inhibitor (TKI). 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, noted Pfizer.

The drug was accepted for filing by the European Medicines Agency for this same indication last summer (The Pharma Letter August 18, 2011).