The National Institute for Health and Care Excellence (NICE) have published draft guidance, recommending Clovis Oncology's cancer treatment, rucaparib, brand name Rubraca▼, as an option, through the Cancer Drugs Fund, for maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.
The full recommendations are expected to be published in November 2019
You can follow developments with Rubraca by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.
Why the committee made these recommendations
The clinical evidence shows that rucaparib extends the time until cancer progresses compared with routine care. How much longer people live after taking rucaparib is uncertain because the data from the trial are not available yet. Because of the uncertainty in the clinical evidence, the estimates of cost effectiveness are very uncertain. Therefore, rucaparib cannot be recommended for routine use in the NHS.
Rucaparib has the potential to be cost effective if further data confirm the estimated overall-survival benefit. Rucaparib is therefore recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, while further data are collected.
About Rubraca (source EMA)
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.
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.
Rubraca was first made available in the EU in 2018. It is manufactured by Clovis Oncology.
European Medicines Agency website page for Rubraca
Links available in External Resources
© NICE 
Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer [ID1485].
In development [GID-TA10383]. Expected publication date: 13 November 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE draft guideline: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.
About Ovarian cancer
About Peritoneal cancer
About Fallopian tube cancer