Click here for Bosulif®▼ (bosutinib monohydrate) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Clinical Papers and Guidelines
Bosulif Clinical Papers
Please use the links below to access the Bosulif clinical papers
Cortes JE et al. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. Journal of Clinical Oncology 2018; 36(3): 231-7
View the paper
This clinical paper has been certified by Pfizer Ltd. in accordance with the ABPI Code of Practice and contains promotional information and is intended for UK Healthcare Professionals. PP-BOS-GBR-0970. March 2020
Indication1:
BOSULIF is indicated for the treatment of adult patients with:
Newly-diagnosed chronic phase (CP) Philadelphia chromosomepositive 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) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options
Posology1:
Newly-diagnosed CP Ph+ CML: The recommended dose is 400 mg bosutinib once daily.
CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy: The recommended dose is 500 mg bosutinib once daily.
In clinical trials for both indications, treatment with bosutinib continued until disease progression or intolerance to therapy.
Guidelines
ELN CML 2020 Guidelines
Understand the differences between the 2013 and 2020 Guidelines
Download here
NICE APPROVED3
BOSULIF (bosutinib) is approved as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:
- they have previously had 1 or more tyrosine kinase inhibitor and
- imatinib, nilotinib and dasatinib are not appropriate and
- the company provided bosutinib with the discount agreed in the patient access scheme (as revised in 2016)
Scottish Medicines Consortium (SMC)4
Statement from Scottish Medicines Consortium website on Bosulif
Following a re-submission considered under the ultra-orphan medicine process1:
Bosutinib (Bosulif) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Major cytogenetic response was achieved in 23/52 patients who represented “unmet medical need” within a non-comparative phase I/II study, in which the full population included 546 patients with CP, AP or BP imatinib pre-treated Ph+ CML.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bosutinib. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
- BOSULIF Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/7943/smpc. Accessed: March 2021.
- Hochhaus A et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966-984
- NICE Technology Appraisal Guidance (TA401). Bosutinib for previously treated chronic myeloid leukaemia. Available at: https://www.nice.org.uk/guidance/ta401. Published: 24 August 2016. Accessed: March 2021.
- SMC (910/13). Available at: https://www.scottishmedicines.org.uk/medicines-advice/bosutinib-bosulif-resubmission-91013/ Published: 9 February 2015. Accessed: March 2021.
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