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EfficacyEfficacyBosulif EfficacyBFORE StudyBFORE 5-year dataBYOND StudyStudy 200Study 200 extensionSafetyDosingSupport & ResourcesSupport & ResourcesResource overviewGuidelinesNew challenges videoVideosMaterials

The content of this website has been produced in line with the BOSULIF® (bosutinib) Summary of Product Characteristics for Great Britain and Northern Ireland. For BOSULIF® (bosutinib) Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

Durable responses in second-line therapy after >8 years1Study 200 extension: Long-term efficacy and safety profile of BOSULIF for second-line therapy

Cytogenetic response in all evaluable patients

Example

9-year probability of maintaining a response*

Evaluable patients had a valid baseline assessment. CCyR was imputed from MMR in the extension study. Molecular data are not available for patients in some regions. Median (range) follow-up was 54 (1–155) months (CP 2nd-line). *Kaplan-Meier estimate for responders only.
Criteria used: Resistant mutation; medical history or evidence of prior TKI intolerance.

Evaluable patients had a valid baseline assessment. CCyR was imputed from MMR in the extension study. Molecular data are not available for patients in some regions. Median (range) follow-up was 54 (1–155) months (CP 2nd-line).
Patients without evaluable baselines (MCyR n=204, CCyR n=246).
​​​​​​​*Kaplan-Meier estimate for responders only.
Criteria used: Resistant mutation; medical history or evidence of prior TKI intolerance.

Please refer to the BOSULIF SmPC for full details of adverse events Loading

No new safety signals at >8 years

Most common new TEAEs across cohorts since Year 5 were pleural effusion (n=18), arthralgia (n=14), anaemia (n=13), increased blood creatinine (n=13) and pneumonia (n=13).

New challenges: long term TKI therapy

Hear Dr. Alex Lyon's views on long-term TKI treatment in an ageing patient population

Learn moreLoading
Review ELN Guidelines

Compare 2013 guidelines to those published in 2020
​​​​​​​

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CCyR, complete cytogenetic response; CI, confidence interval; CML, chronic myelogenous leukaemia; CP, chronic phase; MCyR, major cytogenetic response; MMR, major molecular response; TEAE, treatment-emergent adverse
event; TKI, tyrosine kinase inhibitor.

References:

Brümmendorf TH, et al. Presented at the American Society of Hematology Annual Meeting, 2020; Abstract 2152.
Available at: https://ash.confex.com/ash/2020/webprogram/Paper137208.html (last accessed June 2022).
PP-BOS-GBR-1639. June 2022

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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