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FDA Approves Pfizer's Bosulif For Patients With Previously Treated Ph+ CML

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9/4/2012 4:43 PM ET

Pfizer Inc. (PFE: Quote) announced that the U.S. Food and Drug Administration or 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 or CML with resistance, or intolerance to prior therapy.

The company said 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 or 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 a kinase inhibitor that limits cancer cell growth by inhibiting the Abl and Src signaling pathways. The recommended dose of Bosulif is 500 mg, orally, taken once daily, with food.

The company said that the most common adverse reactions observed in greater than 20 percent of the patients in the Phase 1/2 safety population (n=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia and fatigue.

Pfizer said that BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving Bosulif.

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by RTT Staff Writer

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