Bosulif Recommended by SMC for Chronic Myeloid Leukaemia

The Scottish Medicines Consortium (SMC) has approved Pfizer’s Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukaemia, within NHS Scotland.

The treatment has been approved for patients who have previously been treated with one or more tyrosine kinase inhibitors, and for whom imatinib, nilotinib and dasatinib are not considered potential treatments.

Chronic Myeloid Leukaemia (CML) is caused by a change in the genetic code in some of the cells in the bone marrow which creates an abnormal chromosome called the Philadelphia chromosome. The Philadelphia chromosome makes an enzyme called tyrosine kinase that signals the body to make more white blood cells than the body needs. Around 60 people in Scotland were diagnosed with Chronic Myeloid Leukaemia in 2012.

The regulatory approval was based upon a phase I/II two-part clinical study of 571 patients. In an analysis of a subgroup of patients who could not take other tyrosine kinase inhibitors, a major cytogenetic response was achieved in 23 out of 52 of those treated with bosutinib.

The Professor of Translational Haematology at the University of Glasgow, Mhairi Copland, commented that the “decision provides a treatment option for eligible CML patients whose current therapies are no longer working or are causing significant side effects.”

Elsewhere in the UK patients do not have routine access to bosutinib. Patients in Wales and Northern Ireland have no routine access to the medicine, whilst in England, some eligible patients can access bosutinib via the Cancer Drugs Fund.

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