Pfizer receives FDA approval for BOSULIF to treat Ph+ chronic myelogenous leukemia

Pfizer Inc. 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 [Gleevec®] 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.    

"BOSULIF is the third new medicine from Pfizer Oncology's pipeline to be approved by the FDA in just 13 months, a remarkable achievement that reflects our commitment to advancing the science in cancer drug development and delivering on Pfizer's innovative core," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "By focusing our pipeline on those compounds best positioned for advancement, we have been able to bring yet another important therapy to patients who urgently need it."

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. 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.   

"BOSULIF is an important new addition to the CML treatment landscape," said Dr. Jorge E. Cortes, deputy chair and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and a lead investigator of the Pfizer-sponsored registrational study. "Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors."

"As the first therapy in our growing hematology portfolio to receive approval by the FDA, BOSULIF exemplifies Pfizer's commitment to bringing meaningful new medicines to patients with hematologic cancers," said Mace Rothenberg, vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "We believe many doctors and CML patients will find this treatment to be a welcome addition, offering a distinct adverse event profile and a convenient once-daily dosing regimen."