FDA approves expanded indication for Keytruda (pembrolizumab) as first line treatment for melanoma- MSD

The FDA has approved an expanded indication for Keytruda (pembrolizumab), from MSD, 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 per kg every three weeks.

In a Phase III 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 per kg every two weeks demonstrated a 37 percent reduction in the risk of death and those given Keytruda 10 mg per kg every three weeks demonstrated a 31 percent reduction in the risk of death, both compared to ipilimumab.

Comment: The first cancer drug in the US to block the PD-1 pathway, Keytruda is intended for use following treatment with Yervoy (ipilimumab), while for melanoma patients whose tumours express the BRAF V600 gene mutation, Keytruda can be used after Yervoy and a BRAF inhibitor, like Zelboraf (vemurafenib) and Tafinlar (dabrafenib).