FDA approves pembrolizumab for Merkel cell carcinoma
Source: Ecancer News, January 2019
The Food and Drug Administration has granted accelerated approval to pembrolizumab for adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multi-centre, non-randomised, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease.
Patients received pembrolizumab 2 mg/kg every 3 weeks.