The indication of Keytruda 2mg/kg every three weeks is approved under accelerated approval based on tumor response rate and durability of response.
Keytruda, the first anti-programmed death receptor-1 (PD-1) drug approved in the US, is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to fight advanced melanoma.
The drug received FDA’s Breakthrough Therapy status for advanced melanoma based on the significance of early study findings and the unmet medical need.
The drug works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells.
The company is conducting ongoing Phase II and III clinical trial in advanced melanoma, which are designed to provide further confirmatory evidence for Keytruda in this indication.