KENILWORTH (NJ) (dpa-AFX) - Merck (MRK) said the FDA has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, to include an every-six-weeks dosing schedule option for melanoma and other indications. If approved, KEYTRUDA 400 mg every-six-week dosing option would be available for use in adults in addition to the currently approved dose of 200 mg every-three-week option. The FDA has set a PDUFA date of Feb. 18, 2020.
In the European Union, 400 mg every-six-week dosing for KEYTRUDA monotherapy was approved in March.
Copyright RTT News/dpa-AFX