Merck announced the U.S. FDA has issued a Complete Response Letter towards six supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for Keytruda (pembrolizumab) in multiple indications. Merck was seeking FDA approval of a 400 mg every six weeks (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. The currently approved dose of Keytruda is 200 mg every three weeks (Q3W) infused over 30 minutes.
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.
About Keytruda (pembrolizumab)
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.