Regulatory approval

Published by the Health Service Executive. Approved

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.

Reimbursement

CDS

Citation

Bosutinib Monotherapy, 2021, version number 4, NCCP National SACT Regimen, viewed 26/03/2026, https://healthservice.hse.ie/documents/6943/224_v4_Bosutinib_Monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Bosutinib

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2013-12-20	Health Service Executive	Indication approved for reimbursement.