Rubraca

rucaparib

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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.

How is Rubraca used?

Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.

Rubraca is available as tablets of 200, 250 and 300 mg. The recommended dose of Rubraca is 600 mg twice a day. The treatment should continue until the cancer progresses or the patient has unacceptable side effects.

Treatment may be interrupted and doses may be reduced in patients who have certain side effects.

For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.

How does Rubraca work?

The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADP-ribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells). In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes. Therefore, when PARP proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.

What benefits of Rubraca have been shown in studies?

The effectiveness of Rubraca was shown in two ongoing studies involving 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines. All patients received Rubraca only.

The combined results from the two ongoing studies showed that of the 79 patients whose disease responded to platinum-based medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).

What are the risks associated with Rubraca?

The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, and thrombocytopenia (low levels of platelets). For the full list of side effects of Rubraca, see the package leaflet.

Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment. For the full list of restrictions, see the package leaflet.

Why is Rubraca authorised in the EU?

Rubraca had a beneficial and durable effect in patients with ovarian cancer with BRCA mutation, whose cancer was sensitive to platinum-based medicines. These benefits are considered clinically relevant considering that patients who can no longer take platinum-based medicines have limited treatment options.

Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment. In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.

The European Medicines Agency decided that although further study was needed to better understand the size of the benefit, Rubraca’s benefits are greater than its risks and it can be authorised for use in the EU.

Rubraca has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Rubraca?

Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.

What measures are being taken to ensure the safe and effective use of Rubraca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Rubraca are continuously monitored. Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.

Other information about Rubraca

Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.

Name Language First published Last updated
Rubraca : EPAR - Medicine overview BG = bălgarski 2018-05-31  
Rubraca : EPAR - Medicine overview ES = español 2018-05-31  
Rubraca : EPAR - Medicine overview CS = čeština 2018-05-31  
Rubraca : EPAR - Medicine overview DA = dansk 2018-05-31  
Rubraca : EPAR - Medicine overview DE = Deutsch 2018-05-31  
Rubraca : EPAR - Medicine overview ET = eesti keel 2018-05-31  
Rubraca : EPAR - Medicine overview EL = elliniká 2018-05-31  
Rubraca : EPAR - Medicine overview EN = English 2018-05-31  
Rubraca : EPAR - Medicine overview FR = français 2018-05-31  
Rubraca : EPAR - Medicine overview LV = latviešu valoda 2018-05-31  
Rubraca : EPAR - Medicine overview LT = lietuvių kalba 2018-05-31  
Rubraca : EPAR - Medicine overview HU = magyar 2018-05-31  
Rubraca : EPAR - Medicine overview MT = Malti 2018-05-31  
Rubraca : EPAR - Medicine overview NL = Nederlands 2018-05-31  
Rubraca : EPAR - Medicine overview PL = polski 2018-05-31  
Rubraca : EPAR - Medicine overview PT = português 2018-05-31  
Rubraca : EPAR - Medicine overview RO = română 2018-05-31  
Rubraca : EPAR - Medicine overview SK = slovenčina 2018-05-31  
Rubraca : EPAR - Medicine overview SL = slovenščina 2018-05-31  
Rubraca : EPAR - Medicine overview FI = suomi 2018-05-31  
Rubraca : EPAR - Medicine overview SV = svenska 2018-05-31  
Rubraca : EPAR - Medicine overview HR = Hrvatski 2018-05-31  

This EPAR was last updated on 31/05/2018 .

Authorisation details

Product details

Product details for Rubraca
NameRubraca
Agency product numberEMEA/H/C/004272
Active substance

rucaparib camsylate

International non-proprietary name (INN) or common name

rucaparib

Therapeutic area Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Rubraca
Marketing-authorisation holder

Clovis Oncology UK Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union24/05/2018

Contact address:

Clovis Oncology UK Limited
Sheraton House 
Castle Park 
Cambridge CB3 0AX
United Kingdom

Product information

Product information

24/05/2018  Rubraca -EMEA/H/C/004272 --

Name Language First published Last updated
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Product Information HR = Hrvatski 2018-05-31  

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  
Rubraca : EPAR - All Authorised presentations HR = Hrvatski 2018-05-31  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Rubraca : Orphan maintenance assessment report HR = Hrvatski 2018-05-31  
Rubraca : EPAR - Public assessment report HR = Hrvatski 2018-05-31  
CHMP summary of positive opinion for Rubraca HR = Hrvatski 2018-03-23  

Authorised

This medicine is approved for use in the European Union

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