Xofigo
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
EMA restricts use of prostate cancer medicine Xofigo
Medicine to be used only after two previous treatments or when other treatments cannot be taken
On 26 July 2018, the European Medicines Agency concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
Xofigo must also not be used with the medicines Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone. Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy). The medicine should also not be used in patients who have no symptoms, in line with the current indication; in addition, the use of Xofigo is not recommended in patients with a low number of bone metastases called osteoblastic bone metastases.
The review of Xofigo was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone. The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms. In addition, the combination used in this study is now contraindicated. In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo. In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination.
It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture. However, the reasons for a possible earlier death seen in this study are not fully understood. The company that markets Xofigo will have to conduct studies to further characterise these events and clarify the mechanisms behind them.
The PRAC’s recommendations were endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP). The European Commission issued a final legal decision valid throughout the EU on 28 September 2018.
Key facts
About this medicine
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Approved name |
Xofigo
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International non-proprietary name (INN) or common name |
radium Ra223 dichloride |
Associated names |
Xofigo
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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-20/1459/C/002653/0028
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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. |
Decision making model |
PRAC-CHMP-EC
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Authorisation model |
Centrally authorised product(s)
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Key dates and outcomes
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Procedure start date |
30/11/2017
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PRAC recommendation date |
12/07/2018
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CHMP opinion/CMDh position date |
26/07/2018
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EC decision date |
28/09/2018
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Xofigo Article-20 procedure - Review started (PDF/76.38 KB)
First published: 01/12/2017
Last updated: 01/12/2017
EMA/789952/2017
Xofigo Article-20 procedure - PRAC list of questions (PDF/75.56 KB)
First published: 01/12/2017
Last updated: 01/12/2017
EMA/PRAC/790594/2017
Xofigo Article-20 procedure - Notification (PDF/143.63 KB)
First published: 01/12/2017
Last updated: 01/12/2017
Xofigo Article-20 procedure - Timetable for the procedure (PDF/73.87 KB)
First published: 01/12/2017
Last updated: 15/06/2018
EMA/PRAC/791811/2017
Under evaluation
Xofigo Article-20 procedure - Assessment report on provisional measures (PDF/916.85 KB)
First published: 21/03/2018
Last updated: 21/03/2018
EMA/176752/2018
Xofigo Article-20 procedure - Scientific conclusions (PDF/39.47 KB)
First published: 21/03/2018
Last updated: 21/03/2018
Xofigo Article-20 procedure - Annex I-II-III (PDF/535.61 KB)
First published: 09/03/2018
Last updated: 09/03/2018
Xofigo Article-20 procedure - Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone (PDF/96.06 KB)
First published: 09/03/2018
Last updated: 09/04/2018
EMA/146483/2018
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Xofigo Article-20 procedure - Annex IV (PDF/77.6 KB)
First published: 11/10/2018
Xofigo Article-20 procedure - Annex I, II, III (PDF/375.94 KB)
First published: 11/10/2018
Xofigo Article-20 procedure - Assessment report (PDF/1.62 MB)
First published: 11/10/2018
EMA/540557/2018
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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27/07/2018
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27/07/2018
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13/07/2018
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15/06/2018
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09/03/2018
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09/03/2018
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12/01/2018
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01/12/2017