Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved ponatinib for reimbursement as a monotherapy treatment option for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (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 as:
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.
Citation
PONATinib Therapy, 2021, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/medonc/cdmp/ponatinib-therapy-302.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ABL1 p.T315I | Chronic Myelogenous Leukemia | Ponatinib |