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


EMA recommends restricting use of cancer medicine Rubraca

On 21 July, EMA’s human medicines committee, CHMP, recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy.

The recommendation followed the review of final data from the ARIEL4 study,1 which compared Rubraca with chemotherapy in patients whose cancer had come back after at least two previous treatments and who were still eligible for further chemotherapy. The final analysis of overall survival showed that Rubraca was not as effective as chemotherapy at prolonging patients’ lives: those treated with Rubraca lived for an average of 19.4 months, compared with 25.4 months for patients receiving chemotherapy.

As a result, doctors should not start third-line treatment with Rubraca in new patients. Doctors should inform patients already receiving Rubraca for this indication of the latest data and recommendations, and consider other treatment options.

This recommendation does not affect the use of Rubraca as maintenance treatment following chemotherapy.


Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
Associated names
Other antineoplastic agents
About this procedure
Current status
European Commission final decision
Reference number
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)
Decision making model
Key dates and outcomes
CHMP opinion date
EC decision date

All documents

Procedure started

  • List item

    Rubraca Article-20 referral - Annex IV (PDF/108.73 KB)

    First published: 23/05/2022

  • List item

    Rubraca Article-20 referral - Assessment report on temporary measures (PDF/238.27 KB)

    First published: 06/05/2022

  • List item

    Rubraca Article-20 referral - Timetable for the procedure (PDF/99.53 KB)

    First published: 22/04/2022
    Last updated: 24/06/2022
    EMA/CHMP/223739/2022 rev1

  • List item

    Rubraca Article-20 referral - Notification (PDF/371.49 KB)

    First published: 22/04/2022

  • List item

    Rubraca Article-20 referral - CHMP List of questions (PDF/145.24 KB)

    First published: 22/04/2022

  • European Commission final decision

  • List item

    Rubraca Article-20 referral - EMA recommends restricting use of cancer medicine Rubraca (PDF/153.59 KB)

    First published: 22/04/2022
    Last updated: 17/10/2022

  • List item

    Rubraca Article-20 referral - Annex IV (PDF/734.52 KB)

    First published: 17/10/2022

  • List item

    Rubraca Article-20 referral - Public assessment report (PDF/1.08 MB)


    First published: 28/09/2022

  • List item

    Rubraca – EPAR – Product Information

    First published: 23/05/2022
    Last updated: 17/10/2022

  • 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.


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