Posted by Michael Wonder on 04 Jun 2017
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma
18 December 2015 - Keytruda is now the first and only anti-PD-1 therapy to achieve superior overall survival compared to ipilimumab.
Merck today announced that the U.S. FDA has approved an expanded indication for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for Keytruda, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of Keytruda is 2 mg/kg every three weeks.
In a Phase 3 trial, KEYNOTE-006, patients with unresectable or metastatic melanoma who were treated with Keytruda experienced superior overall survival compared to those treated with ipilimumab. In this study supporting the first-line approval, patients given KEYTRUDA 10 mg/kg every two weeks demonstrated a 37% reduction in the risk of death and those given Keytruda 10 mg/kg every three weeks demonstrated a 31% reduction in the risk of death, both compared to ipilimumab (hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and hazard ratio: 0.69 [95% CI: 0.52, 0.90; p=0.004], respectively).
