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PP-BOS-GBR-1043 | January 2021
Click here to view the prescribing information for Bosulif® (bosutinib)
BOSULIF® has been authorized 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.
Bosulif is indicated for the treatment of adult patients with:
• Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
• CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
The therapeutic landscape for treating chronic myeloid leukemia (CML) has gone through many changes in the past few years. These changes include the approval of several kinase inhibitors (TKIs) and the subsequent evolution of treatment goals for patients.
In 2020, an update to the European LeukemiaNet (ELN) recommendations for treating CML was published in Leukemia – seven years since the last update in 2013. These updated recommendations were compiled by a panel of 34 experts from across the globe who critically reviewed the published literature since 2013, as well as abstracts presented at recent international meetings.
These recommendations include updates on the use of baseline prognostic factors, definitions of response, first/second-line treatment options including patients with resistance mutations and more.1
In the first podcast below, Professor Richard Clark gives a summary of the main updates to the recommendations, and then more specifically on what the implications are for bosutinib following this update in the second podcast.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App store. Adverse events should also be reported to Pfizer Ltd on 01304 616161.
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