The National Institute for Health and Care Excellence (NICE) has published guidance for Lilly's breast cancer treatment abemaciclib (brand name Verzenios) with another medicine, an aromatase inhibitor, for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
NICE state that 'Abemaciclib with an aromatase inhibitor is recommended as an option for treating breast cancer that is:
- locally advanced or metastatic - the cancer is 'advanced' at the original site or has spread to other parts of the body
- hormone receptor-positive - the cancer cells grow in response to the hormone oestrogen or progesterone
- human epidermal growth factor receptor 2 (HER2)-negative - where the cancer cells lack the HER2 protein on their surface. HER2 helps control cell growth.
NICE have approved abemaciclib for treating breast cancer as first line endocrine-based therapy in adults.
Abemaciclib is recommended only if the manufacturer provides it according to the commercial arrangement.
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.
For more information see full article.
You can follow 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
Palbociclib or ribociclib, taken with an aromatase inhibitor, are usually the first treatments for locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer. They are cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors, as is abemaciclib.
Clinical trial evidence shows that abemaciclib with an aromatase inhibitor increases how long people live without their disease getting worse, compared with an aromatase inhibitor alone. It is not known whether abemaciclib increases the length of time people live, because the final trial results are not available yet. Abemaciclib, palbociclib and ribociclib have different side effects, but they all appear to work as well as each other.
Taking into account the commercial arrangements for all the CDK 4/6 inhibitors, abemaciclib is a cost-effective use of NHS resources and it can be recommended.
About Verzenios (source EMA)
Verzenios is a cancer medicine used to treat women with breast cancer that is advanced or has spread to other parts of the body. Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).
It is used together with a hormonal medicine, either an aromatase inhibitor or fulvestrant.
In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
The active substance in Verzenios, abemaciclib, blocks the activity of enzymes known as cyclin- dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide. In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably. By blocking CDK4 and CDK6, Verzenios slows the growth of HR-positive breast cancer cells.
Verzenios was first made available in the EU in 2018. It is manufactured by Eli Lilly.
European Medicines Agency website page for Verzenios
Links available in full article
© NICE  Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer 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 information on Verzenios
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.