The safety and effectiveness of Bosulif was evaluated in a single clinical trial that enrolled 546 adult patients who had chronic, accelerated or blast phase CML. All patients had disease that progressed after treatment with imatinib or imatinib followed by dasatinib and/or nilotinib, or who could not tolerate the side effects of prior therapy. All patients in the trial were treated with Bosulif.

"BOSULIF is the third new medicine from Pfizer Oncology's pipeline to be approved by the FDA in 13 months," said Mr Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "By focusing our pipeline on those compounds best positioned for advancement, we have been able to bring yet another important therapy to patients who urgently need it."