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NICE recommend cemiplimab (Libtayo▼) for treatment of cutaneous squamous cell carcinoma

Libtayo▼, for Head and neck cancer and Squamous cell carcinoma from Sanofi

The National Institute for Health and Care Excellence (NICE) have recommended that Sanofi's skin cancer treatment cemiplimab, brand name Libtayo▼, be made available on the NHS for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended only if the conditions in the managed access agreement are followed.

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About Libtayo (source EMA)
Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It is used in patients who cannot have surgery or treatment with radiation to cure their disease.

The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.

Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.

Libtayo was first made available in the EU in 2019. It is manufactured by Sanofi.

European Medicines Agency website page for Libtayo
Accessed 13/09/19
Links available in External Resources

© NICE [2019]

Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma. Technology appraisal guidance [TA592]. Published date: 07 August 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 All NICE guidance is subject to regular review and may be updated or withdrawn.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 information on Libtayo

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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