FDA Grants Accelerated Approval for Bosulif

The FDA granted accelerated approval for Bosulif (bosutinib), a drug being developed by Pfizer to treat patients with newly diagnosed chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

The drug was approved based on data from a randomized, open label, multi-center trial involving 487 patients who randomly received either 400mg of bosutinib or imatinib once daily.

Bosutinib was first approved by the FDA in 2012, when it was used in the treatment of chronic, accelerated or blast phase Ph+ CML with an intolerance or resistance to previous therapy.