The U.S. Food and Drug Administration expanded the indication for Pfizer Inc.'s Bosulif to include adult patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
Chronic myelogenous leukemia is a rare blood cancer, which begins in the bone marrow, but often moves into the blood. It accounts for 10% to 15% of all incident leukemia cases.
Bosulif is currently indicated in the U.S. and the EU for the treatment of chronic, accelerated or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia in adult patients who are resistant or intolerant to prior therapy.
The approval is based on the results from a phase 3 study, conducted along with Avillion LLP, showing Bosulif's superiority over imatinib. The continued approval for this indication is contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow-up trial.
Pfizer and Avillion entered into an exclusive collaborative development agreement in 2014 to conduct the trial. Under the agreement, Avillion provided funding and conducted the trial to generate the clinical data that will be used to support potential regulatory filings for marketing authorization of the drug.