Libtayo
cemiplimab
Table of contents
Overview
Libtayo is a cancer medicine used in adults to treat:
- 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;
- a type of skin cancer called basal cell carcinoma (BCC) when the cancer is locally advanced or metastatic. It is used in patients who cannot tolerate treatment with a type of medicine called a ‘hedgehog pathway inhibitor (HHI)’ or whose disease has worsened after such treatment;
- a type of lung cancer called non-small cell lung cancer (NSCLC) when the cancer is locally advanced and cannot be treated with chemotherapy (medicines to treat cancer) and radiation therapy, or when the cancer is metastatic. It is used either alone in patients whose tumours have a protein called PD-L1 in more than 50% of cells and no mutations in the genes EGFR,ALK and ROS1 involved in the development of NSCLC, or together with platinum-based chemotherapy in patients whose tumours have PD-L1 in at least 1% of the cells and no mutations in the EGFR,ALK and ROS1
- cervical cancer that has come back (recurrent) or is metastatic. It is used in patients whose disease has progressed during or after treatment with platinum-based chemotherapy.
Libtayo contains the active substance cemiplimab.
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List item
Libtayo : EPAR - Medicine overview (PDF/150.11 KB) (updated)
First published: 05/07/2019
Last updated: 17/05/2023
EMA/101482/2023 -
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Libtayo : EPAR - Risk-management-plan summary (PDF/151.79 KB)
First published: 05/07/2019
Last updated: 08/12/2022
Authorisation details
Product details | |
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Name |
Libtayo
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Agency product number |
EMEA/H/C/004844
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Active substance |
Cemiplimab
|
International non-proprietary name (INN) or common name |
cemiplimab
|
Therapeutic area (MeSH) |
Carcinoma, Squamous Cell
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Anatomical therapeutic chemical (ATC) code |
L01XC33
|
Additional 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. |
Publication details | |
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Marketing-authorisation holder |
Regeneron Ireland Designated Activity Company (DAC)
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
28/06/2019
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Contact address |
One Warrington Place |
Product information
24/03/2023 Libtayo - EMEA/H/C/004844 - II/0028
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
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.
LIBTAYO in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
- locally advanced NSCLC who are not candidates for definitive chemoradiation, or
- metastatic NSCLC.
Cervical Cancer
LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
Assessment history
News
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24/02/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 202214/10/2022
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21/05/2021
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26/04/2019