FDA Approves Pembrolizumab in Merkel Cell Carcinoma

December 19, 2018 – The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The approval was based on the phase II CITN-09/KEYNOTE-017 trial (NCT02267603), in which pembrolizumab elicited an overall response rate (ORR) per indedependent review of 56% (95% CI, 41%-70%), as well as a 24% complete response rate and a … (leggi tutto)