FDA Will Review Application Seeking Expansion of Keytruda’s Dosing Schedule

Source: Immuno-Oncology News, August 2019

The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.

Keytruda is a checkpoint blockade immunotherapy developed by Merck(known as MSD outside the U.S. and Canada), which has been approved by the FDA and the European Medicines Agency (EMA) for treating several types of cancer.

It is a monoclonal antibody that has been designed to target and block the activity of the PD-1 receptor (a protein found on the surface of immune cells), preventing cancer cells from avoiding being targeted and killed by immune cells.