Merck & Co. Inc. (MRK), known as MSD outside the United States and Canada, Wednesday announced that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application for Keytruda. It will be reviewed under the FDA’s Accelerated Approval program. The compound is intended for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.
The company noted that the application envisages Keytruda as single agent at a dose of 200 mg administered intravenously every three weeks.
Keytruda is a humanized monoclonal antibody that can increase the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.