European Commission grants conditional marketing approval to Bosulif (Pfizer) for PH+CML

The European Commission (EC) has granted conditional marketing authorization for Bosulif (bosutinib) from Pfizer, in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually.

As part of the conditional approval, Pfizer is committed to generating additional efficacy and safety data for Bosulif in patients with Ph+ CML previously treated with one or more TKIs not suitable for imatinib, dasatinib and nilotinib, and will submit the findings to the European Medicines Agency .