Cemiplimab (Libtayo) for the treatment of advanced non-melanoma skin cancer


Cemiplimab (trade name: Libtayo) has been approved in Germany since June 2019 for the treatment of cutaneous squamous cell carcinoma (CSCC).

CSCC is a type of non-melanoma skin cancer. In most cases it develops on the face or other parts of the body that are regularly exposed to sunlight. It is more common in older people. If CSCC is detected early on, it can usually be completely removed by surgery. Left untreated, it can grow and spread to nearby lymph nodes or even other organs and form distant (metastatic) tumors there.

Cemiplimab can be used to treat advanced local CSCC or metastatic CSCC if surgery or radiotherapy are no longer an option. The aim of treatment with this drug is to stimulate the to fight the cancer.


Cemiplimab enters the bloodstream directly through a drip into a vein (an intravenous infusion). This infusion takes about 30 minutes and is given every three weeks. Treatment is stopped if it is no longer tolerated or if the disease gets worse despite treatment.

Other treatments

There are various treatment options for people who haven't yet had treatment and who can't have surgery or radiotherapy. People who have already been treated are given best supportive care (BSC). The aim of this treatment is to relieve symptoms such as pain, and improve quality of life. It should be tailored to the patient's individual needs.


In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of cemiplimab when compared with the standard treatments for advanced cutaneous squamous cell carcinoma in adults.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of cemiplimab (Libtayo).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Cemiplimab (cutaneous squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V . Dossier assessment; Commission A19-60. October 30, 2019. (IQWiG reports; Volume 832).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on November 21, 2019
Next planned update: 2022


Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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