|Pronunciation||sem' ip li" mab|
|Other names||REGN-2810, REGN2810, cemiplimab-rwlc|
|Main uses||Squamous cell skin cancer, basal cell cancer, non-small cell lung cancer (NSCLC)|
|Side effects||Low thyroid, pneumonitis, skin reactions, high thyroid, inflammation of the liver|
|Typical dose||350 mg q 3 weeks|
|Elimination half-life||19 days|
|Chemical and physical data|
|Molar mass||143569.10 g·mol−1|
Cemiplimab, sold under the brand name Libtayo, is a medication used to treat squamous cell skin cancer, basal cell cancer, and certain non-small cell lung cancer (NSCLC). It is used for advanced cases that cannot be cured by surgery. It is given by injection into a vein.
Common side effects include low thyroid with tiredness and weight gain; pneumonitis with shortness of breath and cough; skin reactions; high thyroid with sweating and weight; and inflammation of the liver. Other side effects may include infusion reactions and muscle pain. Use during pregnancy may harm the baby. It is a monoclonal antibody that binds to programmed death receptor-1 (PD-1), allowing T cells to kill cancer cells.
Cemiplimab was approved for medical use in the United States in 2018 and Europe in 2019. It was approved for medical use in Australia in July 2020. In the United Kingdom it costs the NHS £4,650 every 3 weeks. This amount in the United States costs about $9,800.
Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
It is given at a dose of 350 mg once every 3 weeks.
Cemiplimab is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping cemiplimab. The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Severe reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with cemiplimab.
Cemiplimab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.
Mechanism of action
The safety and efficacy of cemiplimab was studied in two open label clinical trials. A total of 108 participants (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate, or the percentage of participants who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment. Results showed that 47.2 percent of all participants treated with cemiplimab had their tumors shrink or disappear. The majority of these participants had ongoing responses at the time of data analysis.
The U.S. Food and Drug Administration (FDA) granted the application of cemiplimab breakthrough therapy and priority review designations. The FDA granted the approval of cemiplimab-rwlc to Regeneron Pharmaceuticals, Inc.
Cemiplimab is the first FDA approval of a medication specifically for advanced cutaneous squamous cell carcinoma (CSCC).
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