NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and its partner Avillion LLP announced results from the Phase 3 BFORE trial demonstrating superiority of BOSULIF (bosutinib) over imatinib as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myeloid leukemia. The study met its primary endpoint of major molecular response at 12 months. The company said no new or unexpected safety issues were identified.
Pfizer said it will work with the U.S. FDA and other regulatory authorities to potentially make BOSULIF available for Ph+ CML patients in the first-line setting. BOSULIF is currently indicated in the U.S. and EU for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.
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