This site is intended only for healthcare professionals resident in the Republic of Ireland




Sign in or RegisterLog out Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up



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.

Study 200 - Efficacy data in 2nd line and beyondSuitable for your intolerant and resistant CML patients1

BOSULIF® (bosutinib) has been tested in a large number of patients and demonstrates efficacy in a wide range of patient types.1

Patient cohorts (N=574* including patients receiving 1 dose of BOSULIF)2-4

Chronic phase, second-line1,2

Primary cohort: imatinib resistant

Subgroup: imatinib intolerant

Chronic phase, third-/fourth-line3 n=119

IMI-R/I + dasatinib resistant (n=38)
IMI-R/I + dasatinib intolerant (n=50)
IMI-R/I + nilotinib resistant (n=26)
IMI-R/I + nilotinib Intolerant or IMI-R/I + nilotinib-R/I + dasatinib-R/I (n=5)

Accelerated phase4
Blast phase4
Includes 24 patients with Ph+ ALL.4Efficacy in second-line patients and beyond1,2

Primary endpoint: 33% (95% CI, 27–40) MCyR at 24 weeks in imatinib-resistant patients (n=200)1,2

Response rates in all patients by line of therapyMinimum follow-up period was 10 years.Includes patients with a valid baseline assessment.Explore more BFORE study

A Phase 3 study in patients with newly diagnosed CP Ph+ CML.5

View study
BYOND study

A Phase 4 trial in Ph+ CML patients resistant or intolerant to prior therapy.6

View study
AP=accelerated phase; BP=blast phase; CCyR=complete cytogenetic response; CI=confidence interval; CML=chronic myeloid leukemia; CP=chronic phase; ELN=European LeukemiaNet; IMI-R/I=imatinib resistant or intolerant; MCyR=major cytogenetic response; TKI=tyrosine kinase inhibitor. Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF Summary of Product Characteristics Loading

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

References:BOSULIF (bosutinib) Summary of Product Characteristics.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.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.
Efficacy Safety

The safety profile of BOSULIF is well established and includes long-term, cardiac, and vascular data1​​​​​​​

Find out more

Legal Category: S1A
Further information is available upon request

PP-BOS-IRL-0175. 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

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit


This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.


Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.