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EfficacyBOSULIF efficacy​​​​​​​EfficacyLinkLinkLinkLinkBFORE studyBYOND studyStudy 200SafetySafety dataDosingBosulif Dosing informationSupport & ResourcesSupport and ResourcesMaterials

Click here for BOSULIF® (bosutinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

BOSULIF® (bosutinib)

BOSULIF is indicated for the treatment of adult patients with1:

  • Newly-diagnosed chronic phase (CP) Philadelphia chromosome–positive chronic myelogenous leukaemia (Ph+ CML) 
  • 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
BOSULIF is recommended by the ELN guidelines for CML

ELN guidelines recommend BOSULIF (bosutinib) for both 1st- and 2nd-line use in CML2

 View ELN guidelines for CML BFORE study

A Phase 3 study in patients with newly diagnosed CP Ph+ CML.3

 View study BYOND study

A Phase 4 trial in Ph+ CML patients resistant or intolerant to prior therapy.4

 View study Study 200

A study in CP, AP, or BP Ph+ CML patients with resistance or intolerance to prior therapy.5-7

 View study Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF Summary of Product Characteristics Loading
References:Bosulif Summary of Product CharacteristicsHochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966-984.Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237.Hochhaus A, Gambacorti-Passerini C, Abboud C, et al; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND Study. Leukemia. 2020;34(8):2125-2137.Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011;118(17):4567-4576.Cortes JE, Khoury HJ, Kantarjian HM, et al. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol. 2016;91(12):1206-1214.Gambacorti-Passerini C, Kantarjian HM, Kim D-W, et al. Long-term efficacy of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors. Am J Hematol. 2015;90(9):755-768.

Legal Category: S1A
Further information is available upon request

PP-BOS-IRL-0174. Date of Preparation December 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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