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NICE recommend abemaciclib (Verzenios▼) in the treatment of advanced breast cancer

Verzenios▼, for Breast cancer (female) from Eli Lilly

The National Institute for Health and Care Excellence (NICE) have provisionally approved Eli Lilly's breast cancer medicine abemaciclib, brand name Verzenios▼, for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer in adults.

NICE state that Verzenios, with another medicine called fulvestrant, is available through the Cancer Drugs Fund rather than the NHS. This will remain the case while more information is collected. It is a possible option for adults who have locally advanced or metastatic breast cancer that:
  • is hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative and
  • has been treated with endocrine therapy previously and
  • if exemestane plus everolimus would be the most appropriate alternative.
For more information and references, see full article.

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Why the committee made these recommendations
Current treatment for advanced hormone receptor-positive, HER2- negative breast cancer after endocrine therapy when chemotherapy is not needed immediately, is usually exemestane, tamoxifen, or exemestane plus everolimus. NICE does not recommend fulvestrant monotherapy.

Clinical trial evidence suggests that compared with fulvestrant alone, abemaciclib with fulvestrant increases the length of time before the disease progresses. However, it is uncertain whether people having abemaciclib with fulvestrant live longer, because people in the trial have not been followed-up for long enough. This uncertainty in the clinical
benefit adds to the uncertainty about the cost-effectiveness estimates.

The cost-effectiveness estimates are based on an indirect comparison. Also, survival data are incomplete. Therefore the cost-effectiveness estimates are highly uncertain. Most of the plausible estimates are likely to be higher than what NICE normally considers an acceptable use of NHS resources, although the company’s preferred estimate is lower.

Therefore abemaciclib with fulvestrant is not recommended for routine commissioning in the NHS.
More evidence is needed to address clinical uncertainties. Longer followup data from the trial on how long people live is likely to reduce the uncertainty in the clinical and cost-effectiveness results. Therefore abemaciclib with fulvestrant is recommended for use in the Cancer Drugs Fund, while these data are collected.

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
Accessed 09/05/19
Links available in full article

© NICE [2019]

Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy. Technology appraisal guidance [TA579]
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

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