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Libtayo (cemiplimab-rwlc) Injection Approved for Squamous Cell Carcinoma

MONDAY, Oct. 1, 2018 -- Libtayo (cemiplimab-rwlc) injection has been approved by the U.S. Food and Drug Administration to treat advanced squamous cell carcinoma (CSCC), the agency said in a news release.

The drug is from a class of medications called immune checkpoint inhibitors. These drugs target a protein found on the body's immune cells and certain cancer cells called PD-1, the FDA explained. Libtayo is designed to help the body's immune system fight the cancer.

"With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1 pathway for treating a variety of tumors, from bladder to head and neck cancer," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.

About 700,000 people in the United States are diagnosed with CSCC each year, making it the second most common form of skin cancer behind basal cell cancer, the FDA said.

CSCC usually develops on skin that has regularly been exposed to the sun and other sources of ultraviolet radiation, the agency said. When the cancer spreads, it can travel to the lymph nodes or other tissues and organs, potentially becoming life-threatening.

Clinical trials of Libtayo involving 108 people showed that more than 47 percent of those given the drug had their tumors shrink or disappear, the FDA said.

Common side effects include fatigue, rash and diarrhea. A more serious adverse reaction is that the immune system could attack normal organs and tissues.

Since Libtayo may harm a developing fetus, women of child-bearing age should use contraception while taking the drug, the agency said.

Libtayo is produced by Regeneron Pharmaceuticals, based in Tarrytown, N.Y.

© 2020 HealthDay. All rights reserved.

Posted: October 2018

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