Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized ponatinib for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (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 variant.

This is written in the approval document as:

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.

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.