FDA Approves Libtayo (Cemiplimab) for a Type of Skin Cancer

The US Food and Drug Administration (FDA) has approved Libtayo (cemiplimab) to treat people with advanced squamous cell carcinoma of the skin. Most people can be cured with surgery or radiation, but in some cases the cancer becomes advanced and these treatments may no longer be options.

Libtayo is the first drug approved by the FDA specifically for advanced squamous cell carcinoma of the skin. It’s an immunotherapy drug called a checkpoint inhibitor. It works by blocking a protein called PD-1 on certain immune cells. This protein helps cancer cells avoid being found and destroyed by the body’s immune system. Blocking the PD-1 protein helps the immune system recognize the cancer cells and attack them. Libtayo is the 3rd immune checkpoint inhibitor targeting the PD-1 pathway approved by the FDA to treat several different cancer types.

The FDA based its approval on results from 2 clinical trials involving 108 people with advanced squamous cell carcinoma of the skin. All the patients knew they were being given Libtayo. The studies were designed to measure objective response rate, which is the percentage of participants whose tumors either shrank or disappeared after being given Libtayo. Results showed an objective response rate of 47%.

The FDA granted the approval under its breakthrough therapy and priority review programs, which designed to speed up approval of drugs to treat serious diseases.

Libtayo is given intravenously (through an IV). The most common side effects include fatigue, rash, and diarrhea. It can also cause the immune system to attack normal organs and tissues and affect the way they work. These can include the lungs, intestines, liver, hormone glands (adrenal, thyroid), and kidney. There reactions can be severe and life-threatening in some cases. If a woman is pregnant and takes Litayo, the drug could cause harm to the developing fetus.

Libtayo is marketed by Regeneron Pharmaceuticals, Inc.   

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