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Iclusig is a cancer medicine that contains the active substance ponatinib. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
- chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
- acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive’ (Ph+). Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome that leads to the development of leukaemia. The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate. It is also used in patients who have a genetic mutation called ‘T315I mutation’ which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
These diseases are rare, and Iclusig was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 2 February 2010.
Iclusig : EPAR - Summary for the public (PDF/129.99 KB)
First published: 11/07/2013
Last updated: 03/08/2018
Iclusig : EPAR - Risk management plan summary (PDF/156.69 KB)
First published: 11/05/2022
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This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Incyte Biosciences Distribution B.V.
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20/10/2022 Iclusig - EMEA/H/C/002695 - IA/0066
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Protein kinase inhibitors
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
- 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.
See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.
European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig24/10/2014
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots22/11/2013
PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig08/11/2013
European Medicines Agency recommends approval of 44 medicines for human use and six medicines for veterinary use in first half 201331/07/2013