FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

84

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option. Merck is seeking FDA approval of a 400 mg Q6W dose infused over 30 minutes for KEYTRUDA indications in melanoma….

 

http://www.businesswire.com/news/home/20190709005284/en/FDA-Accepts-Merck%E2%80%99s-Supplemental-Biologics-License-Applications