The FDA has approved cemiplimab-rwlc, marketed as Libtayo, as the first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation.
Tarrytown, N.Y.-based Regeneron Pharmaceuticals received approval Oct. 8 following a priority review. The decision was based on results from a phase 3 randomized trial, which showed Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo.
This approval adds to Libtayo’s growing list of indications, which include advanced forms of skin and lung cancers.
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