Bosulif® has been authorised under a conditional approval scheme. Since Bosulif® has been granted a conditional approval, the company that markets Bosulif® will carry out and submit the results of a larger study with Bosulif® in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.1
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 options2
PP-BOS-GBR-0950. February 2020
1) European Medicines Agency. EPAR, bosutinib (EMEA/H/C/002373). Available at: https://www.ema.europa.eu/en/documents/overview/bosulif-epar-medicine-overview_en.pdf [accessed February 2020].
2) BOSULIF Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/7943/smpc. Accessed: February 2020.
3) 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: February 2020.
BOSULIF® (bosutinib) film-coated tablet containing 100 mg, 400 mg or 500 mg bosutinib (as monohydrate)
Legal category: Prescription only medicine. Basic NHS price: BOSULIF 100 mg, 28 tablets £859.17. BOSULIF 400 mg, 28 tablets £3,436.67. BOSULIF 500 mg, 28 tablets £3,436.67.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.