30.09.2022 - European Commission final decision

With the publication of the European Commission Decision on 21 September 2022, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No 726/2004 on "Rubraca - Rucaparib" was completed. The marketing authorisation for the medicinal product for human use 'Rubraca - Rucaparib' granted by Decision C(2018)3344(final) of 24 May 2018 is amended on the basis of the scientific conclusions of that Decision. The indications for use have been restricted and the following indication has been withdrawn: Monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.

25.07.2022 - CHMP opinion

Rubraca® (Rucaparib camsylate): Restriction of use of the cancer medicine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued an opinion at its July 2022 meeting on the use of Rubraca® (Rucaparib-camsylate) as a third-line treatment for patients with recurring cancer after at least two platinum-containing chemotherapies, at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. This will now be forwarded to the European Commission for a legally binding implementing decision. Further information can be found under the link below.

26.04.2022 - Procedure started

EMA has started a review of the cancer medicine Rubraca (rucaparib camsylate) when it is used to treat cancer of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after platinum-based chemotherapy and who can no longer have these medicines.

Further Information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):