Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Ponatinib

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.