Regulatory approval

Published by the Health Service Executive. Approved

Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib, nilotinib and bosutinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

This is written in the approval document.

Reimbursement

CDS

Citation

PONATinib Therapy, 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6954/302_v3a_Ponatinib.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Ponatinib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2016-12-20	Health Service Executive	Indication approved for reimbursement.