EMA Recommends Extensions of Therapeutic Indications for Bosutinib

New indication concerns the treatment of patients with newly-diagnosed chronic phase Philadelphia chromosome-positive CML

On 22 February 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product bosutinib (Bosulif). 

The marketing authorisation holder for this medicinal product is Pfizer Limited. 

The CHMP adopted an extension to the existing indication for Bosulif with new indication for the treatment of newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).  

Therefore, the indications for Bosulif are the treatment of adult patients with: 

  • newly-diagnosed CP Ph+ CML
  • CP, accelerated phase (AP), and blast phase (BP) 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 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.