An overview of Rubraca and why it is authorised in the EU
Rubraca is a cancer medicine for adults with high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Patients taking this medicine must have mutations (defects) in genes known as BRCA and their cancer must respond to treatment with platinum-based medicines (another type of cancer medicine).
Rubraca is for patients who have already had at least two treatments with platinum-based medicines but can no longer have these medicines.
Rubraca contains the active substance rucaparib.
Ovarian cancer is rare, and Rubraca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 October 2012.
Rubraca : EPAR - Medicine overview (PDF/78.2 KB)
First published: 31/05/2018
Last updated: 31/05/2018
Rubraca : EPAR - Risk-management-plan summary (PDF/431.22 KB)
First published: 19/02/2019
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Clovis Oncology UK Limited
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23/01/2019 Rubraca - EMEA/H/C/004272 - II/0001
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Rubraca is indicated as 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.