Xofigo

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Summary

 

Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone

Ongoing clinical trial shows an increased risk of death and fractures

The European Medicines Agency (EMA) is investigating an increased risk of death and fractures reported in an ongoing clinical trial with the prostate cancer medicine Xofigo (radium-223 dichloride).

The clinical trial is comparing Xofigo with placebo (a dummy treatment), both given in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone. It includes prostate cancer patients with no symptoms or only mild symptoms, such as pain. Xofigo is currently authorised for use in patients whose prostate cancer has spread to the bones and is causing symptoms.

A preliminary analysis by an independent committee responsible for overseeing the trial reported a rate of death of 27% (109 out of 401 patients) for the Xofigo combination compared with 20% (82 out of 405 patients) for the placebo combination.

Fractures also occurred more frequently with the Xofigo combination than the placebo combination (24% versus 7%).

Patients in this study are no longer treated with Xofigo and all the patients involved are being monitored closely.

EMA will review the full results of this study as well as other available data to evaluate their impact on the authorised use of Xofigo.

While a full investigation is ongoing, doctors are asked not to use Xofigo in combination with Zytiga and prednisone/prednisolone to treat metastatic castration-resistant prostate cancer patients.

Patients who are currently being treated with Xofigo and have any questions about their treatment should contact their doctor.

More about the medicine

Xofigo is used to treat adult men with cancer of the prostate (a gland of the male reproductive system). It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.

The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy.

Xofigo was authorised in the European Union in November 2013. More information on Xofigo.

More about the procedure

The review of Xofigo has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

Name Language First published Last updated
Xofigo Article-20 procedure - Review started (English only) 2017-12-01  

Key facts

About this medicine

Approved nameXofigo
International non-proprietary name (INN) or common name

radium Ra223 dichloride

Associated names
Class

About this procedure

Current statusProcedure started
Reference numberEMEA/H/A-20/1459/C/002653/0028
TypeArticle 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of manufacturing or safety issues.

Decision making modelPRAC-CHMP-EC
Authorisation modelCentrally authorised product(s)

Key dates and outcomes

Procedure start date30/11/2017

All documents

Procedure started

Name Language First published Last updated
Xofigo Article-20 procedure - Review started EN = English 2017-12-01  
Xofigo Article-20 procedure - PRAC list of questions EN = English 2017-12-01  
Xofigo Article-20 procedure - Timetable for the procedure EN = English 2017-12-01  
Xofigo Article-20 procedure - Notification EN = English 2017-12-01  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (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 / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
Procedure started