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
"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