Pfizer announced that the Food and Drug Administration (FDA) has approved Bosulif (bosutinib) to treat adults with newly-diagnosed chronic phase Philadelphia chromosome-positive myelogenous leukemia (Ph+ CML). 

The FDA’s accelerated approval of the supplemental New Drug Application (sNDA) was based on molecular and cytogenetic response rates from the Phase 3 BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) study (n=487). The primary outcome of the the randomized, multicenter, open-label study was to demonstrate superiority of Bosulif over imatinib at 12 months by comparing major molecular response (MMR), or the proportion of patients in each arm whose levels of the Bcr-Abl1 kinase have dropped below 0.1%.

Bosulif 400mg was associated with a significantly higher rate of patients achieving MMR at Month 12 vs patients receiving imatinib 400mg (47.2% vs 36.9%; P=0.0200).  Complete cytogenetic response (CCyR) rate at Month 12 was higher in Bosulif-treated patients vs imatinib-treated patients (77.2% vs. 66.4%; P=0.0075). 

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Diarrhea, nausea, thrombocytopenia, rash, increased ALT, abdominal pain, and increased AST were reported as the most common adverse reactions (incidence at least 20%) in patients treated with Bosulif.

Bosulif, an oral tyrosine kinase inhibitor (TKI), was initially approved in 2012 to treat adults with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy. It is supplied as 100mg and 500mg strength tablets; the FDA recently approved a 400mg tablet strength. 

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