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EfficacyEfficacyBosulif EfficacyBFORE StudyBFORE 5-year dataBYOND StudyStudy 200Study 200 extensionSafetyDosingSupport & ResourcesSupport & ResourcesResource overviewMaterialsVideosPatient SupportGuidelinesCML Digital ChecklistCML Patient Case StudiesCML Monitoring Video Series New Challenges Video

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 first-line response after
>5 years1,2
BFORE 5-year data:  Long-term efficacy with BOSULIF in adult patients with newly diagnosed CML

*MMR (≤0.1% BCR-ABL1 transcripts on the international scale in patients with ≥3000 ABL transcripts assessed at month 3).
†Adjusted for Sokal risk group and region at time of random assignment.
‡MR4, ≤0.01% BCR-ABL1 transcripts on the international scale.
§MR4.5, ≤0.0032% BCR-ABL1 transcripts on the international scale.
ABL, Abelson; BCR, breakpoint cluster region; CI, confidence interval; CML, chronic myelogenous leukaemia; mITT, modified intention-to-treat; MMR, major molecular response; MR, molecular response; OR, odds ratio.

Long-term AEs generally manageable2
Safety Population*
​​​​​​​

*Patients who received one or more doses of study drug
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CML, chronic myelogenous leukaemia; SmPC, Summary of Product Characteristics.
Adapted from: Brümmendorf TH, et al. Leukemia 2022. doi: 10.1038/s41375-022-01589-y Supplementary materials.

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

References:

BOSULIF Summary of Product Characteristics for Great Britain click here. BOSULIF Summary of Product Characteristics for Northern Ireland click here.   Brümmendorf TH, et al. Leukemia 2022. doi: 10.1038/s41375-022-01589-y [accessed June 2022].
PP-BOS-GBR-1611. June 2022

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

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