The European Commission (EC) has granted conditional marketing authorization for Pfizer's Bosulif (bosutinib) anti-cancer drug in the European Union (EU).
Bosulif is authorized in Europe for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) who earlier received one or more tyrosine kinase inhibitors (TKI) and who are considered inappropriate for treatment options such as imatinib, nilotinib and dasatinib.
Pfizer oncology business unit Europe regional president Andreas Penk said, "The approval of BOSULIF reflects the progress that is being made to address the unmet needs of CML patients in Europe and exemplifies Pfizer's commitment to bringing meaningful new medicines to patients living with hematologic malignancies."
The decision was supported by positive data from study 200, multi-cohort, Phase 1/2 study of Bosulif conducted in over 500 Ph+ CML patients receiving at least one TKI in the past.
