Regulatory approval

Published by the European Medicines Agency. Approved

Iclusig is indicated in adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib 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)	not BCR::ABL1	Acute Lymphoblastic Leukemia	Ponatinib
EMA (1)	ABL1 p.T315I, not BCR::ABL1	Acute Lymphoblastic Leukemia	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.