PONATinib Therapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Ponatinib
HSE (1)	not BCR::ABL1	Acute Lymphoblastic Leukemia	Ponatinib
HSE (1)	ABL1 p.T315I, not BCR::ABL1	Acute Lymphoblastic Leukemia	Ponatinib