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FDA Approves New Treatment 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 metastatic cutaneous squamous cell carcinoma, the agency said in a news release.

Clinical trials of Libtayo, an immune checkpoint inhibitor, involving 108 patients showed that the tumors of more than 47 percent of those given the drug shrank or disappeared, 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. Because Libtayo may harm a developing fetus, women of child-bearing age should use contraception while taking the drug, the agency said.

"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," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement.

The FDA granted this application Breakthrough Therapy and Priority Review designations. Libtayo is produced by Regeneron Pharmaceuticals, based in Tarrytown, N.Y.

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Posted: October 2018