BOSULIF

The actual benefit of BOSULIF in the Marketing Authorisation indication is substantial.

Taking into account limited data from a non-comparative phase I/II study, the Committee considers that as the application currently stands, BOSULIF provides no improvement in actual benefit (non-existent IAB, level V) in the therapeutic strategy for chronic phase, accelerated phase and blast phase CML previously treated with one or more tyrosine kinase inhibitors and where imatinib, nilotinib and dasatinib are not considered appropriate treatment options.