Iclusig

What Iclusig is used for

Iclusig is indicated as monotherapy 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 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. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). 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. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.

Approved use, as published by the European Medicines Agency.

Key facts

Brand

Iclusig

Active substance

ponatinib

Disease area

Leukemia, Myeloid; Leukemia, Lymphoid

Medicine group

Antineoplastic agents;Protein kinase inhibitors

ATC code

L01EA05

Marketing authorisation holder

Incyte Biosciences Distribution B.V.

Authorised in the EU since

2013

Official information

• Iclusig: European public assessment report (EPAR), product information and package leaflet, on the EMA website

In the USA

Same active substance: Iclusig