Zydelig
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Approved name |
Zydelig
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International non-proprietary name (INN) or common name |
idelalisib
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Associated names |
Zydelig
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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/A-20/1439/C/3843/0023
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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 |
17/03/2016
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PRAC recommendation date |
07/07/2016
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CHMP opinion/CMDh position date |
21/07/2016
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EC decision date |
15/09/2016
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Zydelig Article-20 procedure - Annex IV - Scientific conclusions (PDF/51.61 KB)
First published: 02/05/2016
Last updated: 02/05/2016
Zydelig Article-20 procedure - Assessment report on provisional measures (PDF/961.38 KB)
First published: 23/03/2016
Last updated: 23/03/2016
EMA/215033/2016
Zydelig Article-20 procedure - Notification (PDF/47.14 KB)
First published: 18/03/2016
Last updated: 18/03/2016
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
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
Zydelig Article-20 procedure - Annex III (PDF/569.34 KB)
First published: 18/03/2016
Last updated: 18/03/2016
Zydelig Article-20 procedure - PRAC list of questions (PDF/102.94 KB)
First published: 18/03/2016
Last updated: 18/03/2016
EMA/PRAC/197574/2016
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
Zydelig Article-20 procedure - PRAC assessment report (PDF/392.17 KB)
First published: 03/10/2016
Last updated: 03/10/2016
EMA/586939/2016
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
Zydelig Article-20 procedure - Annex IV (PDF/40.95 KB)
First published: 03/10/2016
Last updated: 03/10/2016
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.
News
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22/07/2016
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22/07/2016
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08/07/2016
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08/07/2016
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10/06/2016
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13/05/2016
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15/04/2016
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18/03/2016
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18/03/2016
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11/03/2016