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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.

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
​​​n=288

Primary cohort: imatinib resistant
(n=200)

Subgroup: imatinib intolerant
(n=88)

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

Subgroups:
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
n=79 Blast phase4
n=64 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

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