Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved bosutinib for reimbursement as a treatment option for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotonib, and dasatinib are not considered appropriate treatment options.

This is written in the approval document as:

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, nilotonib and dasatinib are not considered appropriate treatment options.

Citation

Bosutinib Monotherapy, 2021, version number 4, NCCP National SACT Regimen, viewed 19/12/2023, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/224-bosutinib-monotherapy-regimen.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BCR::ABL1 Chronic Myelogenous Leukemia Bosutinib