- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting the ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
It is used as maintenance treatment in patients newly diagnosed with advanced cancer or in patients whose cancer has come back, and in whom the cancer has cleared (partially or completely) after treatment with platinum-based chemotherapy. Rubraca contains the active substance rucaparib.
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 to be taken twice a day. Treatment should continue until the cancer progresses or the patient has unacceptable side effects, and no longer than 2 years for patients newly diagnosed with advanced cancer. Treatment with Rubraca should be started no later than 8 weeks after the patient has finished their treatment with platinum-based chemotherapy.
For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.
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). When PARP proteins are blocked, the damaged DNA in the cancer cells cannot be repaired and the cells die as a result.
Rubraca was investigated in a main study of 564 patients with recurring ovarian cancer which had cleared (partially or completely) after treatment with platinum-based chemotherapy. Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).
Another study looked at 538 patients with newly diagnosed advanced ovarian cancer which had cleared (partially or completely) after treatment with platinum-based chemotherapy. Patients given Rubraca lived for 20 months without the disease coming back or getting worse compared with 9 months in patients given placebo.
For the full list of side effects and restrictions with Rubraca, see the package leaflet.
The most common side effects with Rubraca (which may affect more than 1 in 5 people) include tiredness or weakness, nausea (feeling sick), vomiting, anaemia (low red blood cell counts), abdominal pain (belly ache), dysgeusia (taste disturbances), increased levels of liver enzymes in the blood (which may indicate liver damage), decreased appetite, diarrhoea, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and thrombocytopenia (low levels of platelets).
Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.
Rubraca has been shown to delay worsening or return of the disease in patients whose cancer had cleared partially or completely after treatment with platinum-based chemotherapy. 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 Rubraca’s benefits are greater than its risks and it can be authorised for use in the EU.
Rubraca was originally given ‘conditional authorisation’ because there was more evidence to come about the use of Rubraca outside maintenance treatment of patients. This use has since been restricted1.The authorisation has therefore been switched from a conditional to a standard marketing authorisation.
1Following a review carried out in 2022, the use of Rubraca in patients whose cancer has returned or worsened after two treatments with platinum-based chemotherapy is no longer recommended.
The company that markets Rubraca will provide final results to confirm the effectiveness of Rubraca as a maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has cleared (partially or completely) after treatment with platinum-based chemotherapy.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca have also 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.
Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018. This was switched to a standard marketing authorisation on 9 November 2022.
Rubraca : EPAR - Medicine overview
Reference Number: EMA/469708/2023
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Rubraca : EPAR - Risk management plan
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Product information
Rubraca : EPAR - Product Information
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Latest procedure affecting product information: IAIN/0044
02/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Rubraca : EPAR - All Authorised presentations
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Product details
- Name of medicine
Rubraca
- Active substance
Rucaparib camsylate
- International non-proprietary name (INN) or common name
rucaparib
- Therapeutic area (MeSH)
Ovarian Neoplasms
- Anatomical therapeutic chemical (ATC) code
L01XX
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
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.
Authorisation details
- EMA product number
EMEA/H/C/004272
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
- Marketing authorisation holder
pharmaand GmbH
Taborstrasse 1
1020 Vienna
Austria- Opinion adopted
06/11/2017
- Marketing authorisation issued
23/05/2018
- Revision
17
Assessment history
Rubraca : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (171.95 KB - PDF)
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Rubraca-H-C-4272-II-0036 : Assessment report - Variation
AdoptedReference Number: EMA/CHMP/503870/2023
English (EN) (7.33 MB - PDF)
First published:
CHMP post-authorisation summary of positive opinion for Rubraca (II-36)
AdoptedReference Number: EMA/CHMP/445199/2023
English (EN) (115.74 KB - PDF)
First published:
Rubraca-H-C-4272-II-0029 : EPAR - Assessment report - Variation
AdoptedReference Number: EMA/883431/2022
English (EN) (14.42 MB - PDF)
First published:
Rubraca-H-A-20-1518-C-4272-0033 : Assessment report
AdoptedReference Number: EMA/674344/2022
English (EN) (1.08 MB - PDF)
First published:
Rubraca : EPAR - Scientific conclusions Annex IV
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български (BG) (1.32 MB - PDF)
español (ES) (725.5 KB - PDF)
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dansk (DA) (714.84 KB - PDF)
Deutsch (DE) (739.97 KB - PDF)
eesti keel (ET) (711.82 KB - PDF)
ελληνικά (EL) (737.75 KB - PDF)
français (FR) (723.28 KB - PDF)
hrvatski (HR) (758.94 KB - PDF)
italiano (IT) (715.12 KB - PDF)
latviešu valoda (LV) (756.77 KB - PDF)
lietuvių kalba (LT) (756.49 KB - PDF)
magyar (HU) (753.2 KB - PDF)
Malti (MT) (772.31 KB - PDF)
Nederlands (NL) (719.83 KB - PDF)
polski (PL) (756.21 KB - PDF)
português (PT) (727.02 KB - PDF)
română (RO) (755.04 KB - PDF)
slovenčina (SK) (738.97 KB - PDF)
slovenščina (SL) (754.08 KB - PDF)
Suomi (FI) (715.83 KB - PDF)
svenska (SV) (728.75 KB - PDF)
Rubraca-H-C-PSUSA-00010694-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/526847/2021
English (EN) (161.7 KB - PDF)
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Rubraca : Orphan designation withdrawal assessment report (post-authorisation)
AdoptedReference Number: EMA/22653/2019
English (EN) (279.87 KB - PDF)
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Rubraca-H-C-4272-II-0001 : EPAR - Assessment report - Variation
AdoptedReference Number: EMA/902679/2019
English (EN) (5.56 MB - PDF)
First published:
CHMP post-authorisation summary of positive opinion for Rubraca (II-01)
AdoptedReference Number: EMA/CHMP/830894/2018
English (EN) (67.93 KB - PDF)
First published:
Rubraca : Orphan designation withdrawal assessment report (initial authorisation)
AdoptedReference Number: EMA/272157/2018
English (EN) (154.11 KB - PDF)
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Rubraca : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/238139/2018
English (EN) (5.97 MB - PDF)
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CHMP summary of positive opinion for Rubraca
AdoptedReference Number: EMA/CHMP/723380/2017
English (EN) (69.44 KB - PDF)
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News on Rubraca
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023
EMA recommends restricting use of cancer medicine Rubraca
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
More information on Rubraca
This product is no longer an orphan medicine. It was originally designated an orphan medicine on 10 October 2012. Rubraca was withdrawn from the Community register of orphan medicinal products in November 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Direct healthcare professional communications (DHPC)
- Rubraca (rucaparib): restriction of indication(8/08/2022)
- rucaparib camsylate(6/05/2022)
More information on Rubraca
- EMEA-002760-PIP01-19 - paediatric investigation plan
- Rubraca - referral
- Rubraca - direct healthcare professional communication (DHPC)
Topics
Medicines
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