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Regeneron's Libtayo gains FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, enhancing patient treatment options.
Libtayo’s approval marks the first and only approved Immunotherapy for CSCC.
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FDA approved of Regeneron Pharmaceutical’s Libtayo (cemiplimab-rwlc)as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) who are at an increased risk of recurrence following surgery and radiation.1 Libtayo was reviewed by FDA under Priority Review, a method reserved for medicines representing a potential improvement in efficacy or safety in treatments of series diseases. Libtayo is undergoing an additional regulatory review in the European union, with a decision on its approval anticipated in the first half of 2026.1
"Patients whose CSCC is at a high risk of recurrence following surgery and radiation often have the poorest outcomes. Until now, we lacked options to help prevent a devastating recurrence and immunotherapy was only available for patients with advanced CSCC who were no longer candidates for curative surgery or curative radiation,” said Vishal A. Patel, M.D., associate professor of dermatology and of medicine (hematology/oncology) at the George Washington University School of Medicine & Health Sciences and director of the Cutaneous Oncology Program at the GW Cancer Center. “Many patients who undergo surgical resection of their CSCC are later found, on full pathological evaluation, to be at high risk of recurrence. As the first and only immunotherapy approved in the adjuvant setting, Libtayo represents a practice-changing opportunity for this patient population, backed by compelling data showcasing its ability to significantly improve disease-free survival.”
Libtayo’s approval from FDA is based on data collected from the Phase III C-Post trial, which investigated adjuvant Libtayo compared to placebo in patients diagnosed with CSCC who are at high risk of recurrence after surgery and radiation.1 Results from the study, showed Libtayo’s 68% reduction in risk of disease recurrence or death, compared to patients administered with placebo who have CSCC, and are at high risk of recurrence after surgery and radiation.1
Libtayo’s safety profile is consistent with the known safety profile for Libtayo monotherapy in advanced cancers, with the most common adverse reactions of a single agent in adjuvant CSCC at high risk of recurrence were rash, pruritus, and hypothyroidism.1 Serious adverse reactions were reported in 18% of patients, including pneumonia 1.5%, rash 1.5%, diarrhea 1.5%, adrenal insufficiency 1%, and arrhythmia 1%, in the arm administered with the Libtayo treatment.
“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,” said George D. Yancopoulos, M.D., Ph.D., board co-chair, president and chief scientific officer of Regeneron. “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.”
“CSCC is one of the most common skin cancers in the world, with an estimated 1.8 million cases diagnosed each year in the U.S. alone. While it can often be treated successfully with surgery and radiation, many patients face serious risk of advanced disease recurrences,” said Samantha R. Guild, president, AIM at Skin Cancer Foundation. “This approval is wonderful news for people living with CSCC, and we commend Regeneron for its long-standing commitment to addressing needs in non-melanoma skin cancer through its pioneering research.”
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