Positive CHMP opinion for Bosulif (bosutinib) on variation to marketing authorisation to extend the use of Bosulif to children aged 6 years and older – Pfizer

The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Bosulif. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG. The CHMP adopted a change to the existing indications to extend the use of Bosulif to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form, hard capsules, associated with two new strengths, 50 mg and 100 mg. Following CHMP’s positive opinion, the European Commission will review the changes before they are officially incorporated into the medication’s authorization. The updated summary of product characteristics (SmPC) will be accessible on the EMA website.

Bosulif is indicated for the treatment of adult patients with:

• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
• Adult and paediatric patients aged 6 years and olderwith CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
• Adult patients with CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.