Rubraca

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On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Rubraca, intended for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicinal product on 10 October 2012. The applicant for this medicinal product is Clovis Oncology UK Ltd.

Rubraca will be available as 200 mg, 250 mg and 300 mg film-coated tablet. The active substance of Rubraca is rucaparib, an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes (ATC code: L01XX55) that blocks the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die.

The benefits with Rubraca are its anti-tumour activity as measured by objective response rate and response duration as well its safety profile. The most common side effects are fatigue, nausea, creatinine elevations, liver enzymes elevations, vomiting, anaemia, decreased appetite, dysgeusia, diarrhoea, and thrombocytopenia.

The full indication is: “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”.

It is proposed that Rubraca be prescribed by physicians experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

Name Language First published Last updated
CHMP summary of positive opinion for Rubraca (English only) 2018-03-23  

Key facts

Product details for Rubraca
NameRubraca
INN or common name

rucaparib

Therapeutic area Ovarian Neoplasms
Active substance

rucaparib camsylate

Date opinion adopted22/03/2018
Company name

Clovis Oncology UK Ltd

StatusPositive
Application typeInitial authorisation