Research & Development
US Food and Drug Administration accepts for review six supplemental Biologics License Applications for Merck's KEYTRUDA
11 July 2019 -

The US Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications to update the dosing frequency for United States-based Merck's KEYTRUDA, the company's anti-PD-1 therapy, to include an every-six-weeks dosing schedule option, it was reported yesterday.

The company is seeking FDA approval for a 400mg Q6W dose infused over 30 minutes for KEYTRUDA indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.

If the product is approved, the Q6W dose is to be available for use in adults in addition to the presently approved dose of KEYTRUDA 200mg every three weeks infused over 30 minutes. The FDA has set a Prescription Drug User Fee Act, or target action, date of 18 February 2020. The product is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells. It is a humanised 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 tumour cells and healthy cells.