Iclusig

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

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
Approved name
Iclusig
International non-proprietary name (INN) or common name
ponatinib
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/C/2695/A20/0003
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.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
05/12/2013
PRAC recommendation date
09/10/2014
CHMP opinion/CMDh position date
23/10/2014
EC decision date
15/01/2015
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    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

  • List item

    Iclusig Article-20 procedure - Product information (PDF/283.15 KB)


    First published: 02/03/2015
    Last updated: 02/03/2015

  • List item

    Iclusig Article-20 procedure - Annex IV (PDF/42.02 KB)


    First published: 02/03/2015
    Last updated: 02/03/2015

  • List item

    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

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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