Regulatory approval
Published by the Health Canada.
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 is written in the approval document as:
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
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ABL1 p.T315I, BCR::ABL1 | Acute Lymphoid Leukemia | Ponatinib |