Browse Conditions Browse Medicines

NICE publish appraisal for venetoclax (Venclyxto▼) in treating chronic lymphocytic leukaemia

Venclyxto▼, for Chronic lymphocytic leukaemia from AbbVie

The National Institute for Health and Care Excellence (NICE) have recommended that AbbVie's chronic lymphocytic leukaemia treatment venetoclax, brand name Venclyxto▼, in combination with another medicine rituximab, as an option for treating chronic lymphocytic leukaemia.

The combination treatment is approved in adults who have had at least 1 previous therapy.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.



Why the committee made these recommendations
People with previously treated chronic lymphocytic leukaemia usually have ibrutinib. Clinical trial evidence shows that venetoclax plus rituximab increases how long people live for before their disease gets worse compared with bendamustine plus rituximab (a combination that is not frequently used). There is no trial directly comparing venetoclax plus rituximab with ibrutinib. Indirect comparisons of venetoclax plus rituximab with ibrutinib have limitations, but can be used for decision making because there is no other evidence.

Estimates from the cost-effectiveness analyses range from venetoclax plus rituximab being less costly and more effective to it being less costly and less effective, when compared with ibrutinib. Although it is uncertain how effective venetoclax is compared with ibrutinib, a cost-comparison analysis shows that venetoclax plus rituximab is considered to be a cost-effective use of NHS resources and it is recommended for routine use in the NHS.

About Venclyxto (source EMA)
Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).

Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.

It can also be used on its own in:
  • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment). In these patients, Venclyxto is used when medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
  • patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B‑cell receptor pathway inhibitor have both failed.
The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2. This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows the progression of the disease.

Venclyxto was first made available in the EU in 2016. It is manufactured by AbbVie.

Sources
European Medicines Agency website page for Venclyxto
Accessed 01/05/19
Links available in full article

© NICE [2019] %NICE_TITLE% 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 appraisal: Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia

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 system.

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 condition About medicine