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.
Libtayo contains the active substance cemiplimab.
Libtayo : EPAR - Medicine overview (PDF/119.16 KB)
First published: 05/07/2019
Libtayo : EPAR - Risk-management-plan summary (PDF/151.79 KB)
First published: 05/07/2019
Last updated: 08/12/2022
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|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Squamous Cell
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Regeneron Ireland Designated Activity Company (DAC)
|Date of issue of marketing authorisation valid throughout the European Union||
One Warrington Place
18/11/2022 Libtayo - EMEA/H/C/004844 - II/0026
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Cutaneous Squamous Cell Carcinoma
LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
Basal Cell Carcinoma
LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
Non-Small Cell Lung Cancer
LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
- locally advanced NSCLC who are not candidates for definitive chemoradiation, or
- metastatic NSCLC.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 202214/10/2022