Merck said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding its supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.
The submitted applications are based on pharmacokinetic modeling and simulation data presented at the 2018 ASCO Annual Meeting. These data supported the European Commission approval of 400 mg Q6W dosing for KEYTRUDA monotherapy indications on March 28, 2019. Merck is reviewing the letter and will discuss next steps with the FDA.
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that 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.
Source: Company Press Release