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EMA- CHMP recommends the EU Commission grant a conditional marketing authorisation for 'Bosulif' (bosutinib)
Bosulif was designated as an orphan medicinal product on 4 August 2010.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Bosulif and therefore recommends the granting of the marketing authorisation. The marketing authorisation is conditional.
The approved indication is: “Bosulif is indicated 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) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.”
It is proposed that therapy with Bosulif be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.