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 as a monotherapy for the treatment of pediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-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.

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

Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-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
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-07-15	European Medicines Agency	Indication received approval from the European Commission.