FDA approves expanded indication for Pfizer’s Bosulif

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FDA approves expanded indication for Pfizer’s Bosulif


The Food and Drug Administration has approved a new indication for Pfizer’s Bosulif (bosutinib). The drug is now indicated to treat patients with newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myelogenous leukemia, or Ph+ CML. The approval marks the third approval for hematology in five months for Pfizer, the New York City-based company said.

“Bosulif was Pfizer’s first treatment for hematologic malignancies, and has since become an important treatment option for Ph+ CML patients who are resistant or intolerant to previous therapy. This expanded indication has the potential to make an even greater impact on the lives of patients with CML,” Pfizer Oncology global president Liz Barrett said. “Today’s news marks the third FDA approval for a Pfizer hematology medicine in just five months, a significant achievement that reinforces our commitment to patients living with blood cancers.”

Bosulif was first approved in September 2012 to treat patients with chronic-, accelerated- or blast-phase Ph+ CML with resistance or intolerance to prior therapy.