This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 08/12/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Squamous Cell
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

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.

Publication details
Marketing-authorisation holder
Regeneron Ireland Designated Activity Company (DAC)
Date of issue of marketing authorisation valid throughout the European Union
Contact address

One Warrington Place
Dublin 2
D02 HH27

Product information

18/11/2022 Libtayo - EMEA/H/C/004844 - II/0026

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Product information documents contain:

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.


Assessment history

Changes since initial authorisation of medicine

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