Iclusig (ponatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Takeda Pharmaceuticals U.S.A., Inc. Iclusig (ponatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078669.PDF. Revised February. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
ICLUSIG (ponatinib tablets) is indicated for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML that is T315I mutation positive or where there is prior TKI resistance or intolerance	1
ICLUSIG (ponatinib tablets) is indicated for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ABL1 p.T315I	Chronic Myelogenous Leukemia	Ponatinib
Sensitivity (+)	ABL1 p.T315I, BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib