Posted by Michael Wonder on 18 Dec 2018
European Commission approves Merck’s Keytruda (pembrolizumab) as adjuvant therapy for adults with resected Stage III melanoma
17 December 2018 - First approval for Keytruda in an adjuvant setting in the European Union.
Merck today announced that the European Commission has approved Keytruda, the company’s anti-PD-1 therapy, for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.
This approval is based on data from the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial, conducted in collaboration with the European Organisation for Research and Treatment of Cancer. An updated recurrence-free survival (RFS) data analysis, conducted at the request of the European Medicines Agency, demonstrated that Keytruda significantly prolonged RFS, reducing the risk of disease recurrence or death by 44 percent compared to placebo in the overall population of patients with resected, high-risk stage III melanoma (HR=0.56; 98% CI, 0.44-0.72; p<0.0001).
