The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ fully human monoclonal antibody Libtayo(cemiplimab-rwlc) as an adjuvant therapy for adults with cutaneous squamous cell carcinoma (CSCC).
The approval is intended for patients who face an increased risk of the disease returning after surgery and radiation.
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The agency’s decision to approve the programmed cell death protein 1 inhibitor was expedited through its priority review process.
Meanwhile, an application for the drug is under consideration by the European Union, with an outcome anticipated by the first half of 2026.
The latest approval was granted based on the data of the Phase III C-POST study, which compared the use of adjuvant Libtayo to a placebo in patients.
The study revealed that the antibody reduced the disease recurrence or mortality risk by 68% in comparison to the placebo group.
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By GlobalDataLibtayo’s safety profile aligns with its established safety record when used as a single agent for advanced cancers.
The antibody was developed through the company’s VelocImmune technology.
Regeneron Pharmaceuticals president, chief scientific officer and board co-chair George Yancopoulos stated: “This approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting.
“Now with five FDA-approved indications, Libtayo is firmly established as a strong and versatile PD-1 inhibitor option for patients with a variety of cancers.”
The therapy has already been authorised by health regulatory bodies in more than 30 nations for indications including certain cases of advanced basal cell carcinoma, advanced cervical cancer, and advanced non-small cell lung cancer.
In the US, the antibody is known by its generic name cemiplimab-rwlc for its approved uses, with “rwlc” as its suffix. This is in line with the agency’s guidance on the nonproprietary naming of biological products.
Outside the US, the generic name for Libtayo remains cemiplimab.
The US regulator recently expanded the approval of the company’s Evkeeza for the treatment of homozygous familial hypercholesterolemia in children aged between one and four.
