EMA accepts Pfizer’s bosulif Type II Variation application for Ph+ CML


The European Medicines Agency (EMA) has approved for review a Type II Variation application for the use of Pfizer’s bosulif (bosutinib) to treat patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).

Pfizer’s bosulif is an oral, once-daily TKI that inhibits the Bcr-Abl kinase, which promotes CML, and is also an inhibitor of Src-family kinases.

CML is a rare blood cancer that generates in the bone marrow but often moves into the blood of the patient.

The therapy currently has conditional marketing authorisation in Europe for the treatment of adult patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered suitable treatment options.

In addition, the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted priority review for bosulif for the treatment of newly diagnosed Ph+ CML patients.

Bosulif is currently indicated in the US for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.

"We look forward to working with the FDA in our efforts to expand the label for bosulif to include this important group of patients."

The submissions are based on data obtained from a multi-centre, multinational, open-label Phase III BFORE trial.

Pfizer oncology global product development chief development officer Dr Mace Rothenberg said: “As physicians gained experience with bosulif, they have come to appreciate its favourable risk-benefit profile in patients with Ph+ CML who no longer responded to or could not tolerate prior TKI therapy.

“At the 400mg dose, we believe that the BFORE study demonstrates a similarly favourable risk-benefit in previously untreated patients with Ph-positive CML. We look forward to working with the FDA in our efforts to expand the label for bosulif to include this important group of patients.”

In 2014, the company entered an exclusive collaborative development agreement with Avillion to carry out the BFORE trial.


Image: Chronic myeloid leukaemia. Photo: courtesy of J3D3 via Wikipedia.