Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ABL1 p.T315I and BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

The European Medicines Agency (EMA) has authorized ponatinib for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the p.T315I variant.

This statement is based on a regulatory approval from the European Medicines Agency:

Iclusig is indicated in 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 or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Citation

Incyte Biosciences Distribution B.V. Iclusig (ponatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2013-07-01	European Medicines Agency	Indication received approval from the European Commission.