The European Commission (EC) has granted conditional marketing authorization for Pfizer Inc's Bosulif (bosutinib) in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
“I’m delighted the EC has approved Bosulif as a new addition to the CML treatment landscape in Europe,” said Carlo Gambacorti-Passerini, Professor of Internal Medicine at the University of Milano Bicocca in Italy, Director of the Clinical Research Unit, Section of Haematology at S. Gerardo Hospital in Monza, Italy, and a lead investigator in the Bosulif clinical study. “It’s critical to have additional treatment options for CML patients, because each patient responds to therapy differently and has unique needs. Based on my experience with Bosulif, I believe this once-daily treatment, with its distinct safety profile, offers an important new alternative.”
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 (EMA). Following review of the data by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the EC will consider converting the conditional marketing authorization to a full marketing authorization.
The EC decision was based on data from Study 200, a global, single-arm, open-label, multi-cohort, Phase 1/2 study of Bosulif in more than 500 patients with Ph+ CML who had previously been treated with at least one TKI. The study included separate cohorts for patients with chronic, accelerated and blast phase disease. Data on 52 patients were considered as main evidence for the conditional marketing authorization, as these patients were identified as having an unmet medical need because other TKIs were not considered appropriate treatment options for them due to disease resistance or the risk of severe side effects.
“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 haematologic malignancies,” said Andreas Penk, Regional President of Europe for the Pfizer Oncology Business Unit.
Bosulif is an oral, once-daily, kinase inhibitor, which limits cancer cell growth by inhibiting the Abl and Src signalling pathways. The recommended dose of Bosulif is 500 mg, orally, taken once daily with food. Bosulif was first approved in the US in September 2012 for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance, or intolerance, to prior therapy.