Iclusig (ponatinib) [product information]. EMA.

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
Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL.	1
Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-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

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BCR::ABL1	Acute Lymphoid Leukemia	Cytarabine, Dexamethasone, Methotrexate, Ponatinib, Prednisone, Vincristine
EMA (2)	ABL1 p.T315I	Chronic Myelogenous Leukemia	Ponatinib
EMA (1)	not BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib
EMA (1)	ABL1 p.T315I, not BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib