Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ABL1 p.T315I, BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Acute Lymphoid Leukemia.
Health Canada approved ponatinib for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are not appropriate for other tyrosine kinase inhibitor (TKI) therapy, including those with the T315I mutation or prior TKI resistance or intolerance.
This statement is based on a regulatory approval from the Health Canada:
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