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Pfizer’s Bosulif found superior to Gleevec in phase 3 study in type of leukemia

Pfizer’s cancer drug Bosulif (bosutinib) was found superior to Novartis' Gleevec (imatinib mesylate) in a phase 3 study for first-line treatment of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).

Bosulif is an oral, once-daily, tyrosine kinase inhibitor, which inhibits the Bcr-Abl kinase that promotes CML.

The BFORE study met its primary endpoint of major molecular response (MMR) at 12 months. There were no new or unexpected safety concerns.

About 536 patients were enrolled as part of the study, which was carried out at various sites in North America, Asia and Europe.

Patients were randomized 1:1 to receive Bosulif 400mg or imatinib, a standard of care, for the duration of the study.

Pfizer carried out the trail in partnership with drug development firm Avillion under a collaborative development agreement, which was signed in 2014.

Avillion provided funding and carried out the trial to generate the clinical data that will be used to support potential regulatory filings for marketing authorization of Bosulif as first-line treatment of patients with chronic phase Ph+ CML.

If approved for this indication, Pfizer should make milestone payments to Avillion. Pfizer retains all rights to commercialize Bosulif globally.

Pfizer Global Product Development chief development officer for oncology Mace Rothenberg said: “Since its approval, the efficacy and distinct tolerability profile of BOSULIF has provided an important treatment option for patients with Ph+ CML who are resistant or intolerant to prior therapy. 

“The positive outcome of the BFORE study represents a key step in potentially broadening treatment options for patients in the first-line setting.”

Pfizer said it will now work with the US Food and Drug Administration and other regulatory authorities to potentially make Bosulif available for Ph+ CML patients in the first-line setting.


Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.