Regulatory approval
Published by the Health Service Executive. Approved
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.
Reimbursement
CDS
Citation
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. |