The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of cemiplimab (Libtayo) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals, the manufacturer of the PD-1 inhibitor.
According to Regeneron, the incidence of CSCC in Europe is twice that of melanoma. However, there are currently no treatments approved in the EU for advanced CSCC.
FDA prescribing information for Libtayo. Accessed April 29, 2018. https://bit.ly/2V1wrDu.
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