Posted by Michael Wonder on 20 Feb 2019
FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
19 February 2019 - U.S. approval based on significant recurrence-free survival benefit demonstrated with Keytruda in Phase 3 EORTC1325/KEYNOTE-054 trial.
Merck today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial. This pivotal Phase 3 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), demonstrated that KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in patients with resected, high-risk stage III melanoma (HR=0.57 [95% CI, 0.46, 0.70]; p<0.001). KEYTRUDA is the first anti-PD-1 therapy studied in the adjuvant setting across patients with stage IIIA (>1 mm lymph node metastasis), IIIB and IIIC melanoma.
