Iclusig
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig
On 23 October 2014, the European Medicines Agency (EMA) concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.
Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as 'tyrosine-kinase inhibitors'). The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.
The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be dose-related, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment. Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day. The product information has been updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with 'chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage. Additionally, healthcare professionals should stop Iclusig if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems.
The company that markets Iclusig will provide healthcare professionals with educational material highlighting important risks for which monitoring and/or dose adjustments are recommended and including available data on the relationship between dose of Iclusig and risk of blood vessel blockage.
A study on the safety and benefits of Iclusig is also planned, to help clarify if lower doses of the medicine would carry a lower risk of blood clots or blockages of the blood vessels while still having a beneficial effect in patients with chronic phase CML.
The review of Iclusig was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). During its review, the PRAC assessed available data on the nature, frequency and severity of blood clots or blockage of the arteries or veins and considered the potential mechanism for these side effects. The PRAC also sought the advice of a group of experts in oncology before finalising its recommendations, which was then endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) in its final opinion. The CHMP opinion was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 15 January 2015.
Key facts
About this medicine
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Approved name |
Iclusig
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International non-proprietary name (INN) or common name |
ponatinib
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/C/2695/A20/0003
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Type |
Article 20 procedures
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues. |
Authorisation model |
Centrally authorised product(s)
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Decision making model |
PRAC-CHMP-EC
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Key dates and outcomes
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Procedure start date |
05/12/2013
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PRAC recommendation date |
09/10/2014
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CHMP opinion/CMDh position date |
23/10/2014
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EC decision date |
15/01/2015
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Iclusig Article-20 procedure - Notification (PDF/25.69 KB)
First published: 06/12/2013
Last updated: 06/12/2013
Iclusig Article-20 procedure - PRAC list of questions (PDF/74.58 KB)
First published: 06/12/2013
Last updated: 06/12/2013
EMA/PRAC/746091/2013
Iclusig Article-20 procedure - Timetable for the procedure (PDF/78.74 KB)
First published: 06/12/2013
Last updated: 11/07/2014
EMA/PRAC/746118/2013
Iclusig Article-20 procedure - Review started (PDF/79.44 KB)
First published: 06/12/2013
Last updated: 06/12/2013
EMA/745969/2013
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Opinion provided by Committee for Medicinal Products for Human Use
Iclusig Article-20 procedure - PRAC assessment report (PDF/187.14 KB)
First published: 10/11/2014
Last updated: 10/11/2014
EMA/667786/2014
Iclusig Article-20 procedure - Product information (PDF/399.63 KB)
First published: 24/10/2014
Last updated: 24/10/2014
EMA/641476/2014
Iclusig Article-20 procedure - European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig (PDF/79.58 KB)
First published: 24/10/2014
Last updated: 24/10/2014
EMA/641476/2014
European Commission final decision
Iclusig Article-20 procedure - Product information (PDF/283.15 KB)
First published: 02/03/2015
Last updated: 02/03/2015
Iclusig Article-20 procedure - Annex IV (PDF/42.02 KB)
First published: 02/03/2015
Last updated: 02/03/2015
Iclusig Article-20 procedure - European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig (PDF/91.04 KB)
First published: 02/03/2015
Last updated: 02/03/2015
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.