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Pembrolizumab, marketed as Keytruda TM, has differing approval statuses for the treatment of cutaneous squamous cell carcinoma (cSCC) between the FDA and EMA. The FDA approved pembrolizumab for the treatment of recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) on June 24, 2020. This approval is specifically for cases that are not curable by surgery or radiation. The decision was based on the results of the KEYNOTE-629 (NCT03284424) clinical trial. The recommended dosing regimens are either 200 mg every 3 weeks or 400 mg every 6 weeks.EMA Status
In contrast, the EMA …