24 June 2020 - Today the FDA approved pembrolizumab (Keytruda, Merck & Co) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

Efficacy was investigated in KEYNOTE-629, a multicenter, multi-cohort, non-randomized, open-label trial. The trial excluded patients who had previously received therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody and those with autoimmune disease or a medical condition that required immunosuppression. 

Patients received pembrolizumab 200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months. Assessment of tumour status was performed every 6 weeks during the first year and every 9 weeks during the second year.

Read FDA press release