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DECEMBER 30, 2017

New Indication Granted for Bosutinib to Treat Newly Diagnosed Ph+ CML

By Marie Rosenthal

The FDA approved a new indication for bosutinib (Bosulif, Pfizer) to include adults with newly diagnosed chronic phase, Philadelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML). 

Bosutinib is a tyrosine kinase inhibitor (TKI) that inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src family kinases. 

The approval was based on data from BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment), a