Zydelig

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

Overview

CHMP confirms recommendations for use of Zydelig

Patients should be monitored for infection and given antibiotics during and after treatment

On 21 July 2016 CHMP (EMA's Committee for Medicinal Products for Human Use) confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects. However, following a review it updated recommendations to minimise the risk of serious infections in patients treated with the medicine.

All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped. Patients receiving Zydelig should also be monitored for signs of infection and have regular blood tests to measure the level of white blood cells. Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted. Zydelig should also not be started in patients with any generalised infection.

In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP concluded that treatment with Zydelig can again be started in these patients provided alternative treatments are not suitable and provided that the measures to prevent infection are followed.

The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines. In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field. Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use. The CHMP confirmed the recommendations from the PRAC review, and its opinion was sent to the European Commission which issued a final legally binding decision.


117p deletion or TP53 mutation, see EMA recommends new safety measures for Zydelig (18/03/2016)

Key facts

About this medicine
Approved name
Zydelig
International non-proprietary name (INN) or common name
idelalisib
Associated names
Zydelig
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-20/1439/C/3843/0023
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
17/03/2016
PRAC recommendation date
07/07/2016
CHMP opinion/CMDh position date
21/07/2016
EC decision date
15/09/2016
Outcome
Risk minimisation measures

All documents

Procedure started

  • List item

    Zydelig Article-20 procedure - Annex IV - Scientific conclusions (PDF/51.61 KB)


    First published: 02/05/2016
    Last updated: 02/05/2016

  • List item

    Zydelig Article-20 procedure - Assessment report on provisional measures (PDF/961.38 KB)

    Adopted

    First published: 23/03/2016
    Last updated: 23/03/2016
    EMA/215033/2016

  • List item

    Zydelig Article-20 procedure - Notification (PDF/47.14 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016

  • List item

    Zydelig Article-20 procedure - EMA recommends new safety measures for Zydelig (PDF/82.11 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016
    EMA/201814/2016

  • List item

    Zydelig Article-20 procedure - Timetable for the procedure (PDF/71.29 KB)


    First published: 18/03/2016
    Last updated: 10/06/2016
    EMA/PRAC/196144/2016

  • List item

    Zydelig Article-20 procedure - Annex III (PDF/569.34 KB)


    First published: 18/03/2016
    Last updated: 18/03/2016

  • List item

    Zydelig Article-20 procedure - Review started (PDF/80.3 KB)


    First published: 11/03/2016
    Last updated: 11/03/2016
    EMA/191705/2016

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Zydelig Article-20 procedure - CHMP confirms recommendations for use of Zydelig (PDF/92.06 KB)


    First published: 03/10/2016
    Last updated: 03/10/2016
    EMA/550185/2016

  • List item

    Zydelig Article-20 procedure - PRAC assessment report (PDF/392.17 KB)

    Adopted

    First published: 03/10/2016
    Last updated: 03/10/2016
    EMA/586939/2016

  • List item

    Zydelig Article-20 procedure - CHMP confirms recommendations for use of Zydelig (PDF/92.06 KB)


    First published: 03/10/2016
    Last updated: 03/10/2016
    EMA/550185/2016

  • List item

    Zydelig Article-20 procedure - Annex IV (PDF/40.95 KB)


    First published: 03/10/2016
    Last updated: 03/10/2016

  • 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

    News

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