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
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Incyte Biosciences Distribution B.V.
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05/09/2019 Iclusig - EMEA/H/C/002695 - II/0051
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.
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