Bosutinib (3) – Bosulif®

• Clinical trials
  • In the dossier, the pharmaceutical manufacturer presents the results of the pivotal registration trial 3160A4-200-WW.
  • The pharmaceutical manufacturer’s study portfolio also includes study 3160A4-2203.
  • Both studies are single-arm studies, which do not allow for comparison with the appropriate comparator therapy.

Adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase (CP) of the disease who have been pre-treated with at least one tyrosine kinase inhibitor (TKI) and in whom imatinib, nilotinib and dasatinib are not considered suitable treatment options

• The additional benefit is not proven.
• An additional benefit compared with ponatinib is therefore not proven.

Adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the accelerated phase (AP) and in blast crisis (BC) of the disease, who have been pre-treated with at least one tyrosine kinase inhibitor (TKI) and for whom imatinib, nilotinib and dasatinib are not considered suitable treatment options

• An additional benefit is not proven.
• An additional benefit compared with ponatinib is therefore not proven.

Courtesy translation only, please refer to the German original.