Regulatory approval

Published by the Health Canada. Approved

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

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	ABL1 p.T315I, BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib