Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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 October 2022. Accessed March 7, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ABL1 p.T315I	Chronic Myelogenous Leukemia	Ponatinib