Iclusig

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ponatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 29/10/2019

Authorisation details

Product details
Name
Iclusig
Agency product number
EMEA/H/C/002695
Active substance
ponatinib
International non-proprietary name (INN) or common name
ponatinib
Therapeutic area (MeSH)
  • Leukemia, Myeloid
  • Leukemia, Lymphoid
Anatomical therapeutic chemical (ATC) code
L01XE24
Accelerated assessmentAccelerated assessment

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.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Incyte Biosciences Distribution B.V.
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
01/07/2013
Contact address
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

05/09/2019 Iclusig - EMEA/H/C/002695 - II/0051

Contents

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Pharmacotherapeutic group

  • Antineoplastic agent
  • protein

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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