Iclusig (ponatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ABL1 p.T315I	Chronic Myelogenous Leukemia	Ponatinib
Sensitivity (+)	BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib
Sensitivity (+)	ABL1 p.T315I, BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib