Libtayo
What Libtayo is used for
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. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). 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 … (the exact criteria are in the official EMA product information).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Libtayo
- Active substance
- cemiplimab
- Disease area
- Carcinoma, Squamous Cell
- Medicine group
- Antineoplastic agents
- ATC code
- L01XC33
- Marketing authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Authorised in the EU since
- 2019
Official information
In the USA
Same active substance: Libtayo
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Libtayo used for?
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. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (…
What is the active substance in Libtayo?
Libtayo contains cemiplimab.
Who makes Libtayo?
The EU marketing authorisation holder is Regeneron Ireland Designated Activity Company (DAC).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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