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Investing.com -- Regeneron Pharmaceuticals (NASDAQ:REGN) stock rose 2% Wednesday following the FDA’s approval of its drug Libtayo for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
The FDA granted approval for cemiplimab-rwlc (Libtayo) based on results from the C-POST trial, which demonstrated significant improvement in disease-free survival compared to placebo. The study involved 415 patients with high-risk CSCC who had completed adjuvant radiation therapy.
According to the FDA, patients receiving Libtayo showed substantially better outcomes, with median disease-free survival not reached in the treatment arm compared to 49.4 months in the placebo arm. The hazard ratio was 0.32, representing a 68% reduction in the risk of disease recurrence or death, with a p-value of less than 0.0001.
The recommended dosage is 350 mg intravenously every three weeks for 12 weeks, followed by either 700 mg every six weeks or 350 mg every three weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks.
The application received priority review status from the FDA and utilized the agency’s Real-Time Oncology Review pilot program, which streamlines data submission prior to filing the complete clinical application.
The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
Cutaneous squamous cell carcinoma is the second most common form of skin cancer in the United States, and this approval offers a new treatment option for high-risk patients following conventional therapy.
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