Posted by Michael Wonder on 19 Feb 2020
Merck receives complete response letter from the US FDA for supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule
18 February 2020 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics license applications seeking to update the dosing frequency for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, to include a 400 mg dose infused over 30 minutes every-six-weeks option in multiple indications.
The submitted applications are based on pharmacokinetic modelling and simulation data presented at the 2018 ASCO Annual Meeting. These data supported the European Commission approval of 400 mg six weekly dosing for Keytruda monotherapy indications on 28 March 2019.
Merck is reviewing the letter and will discuss next steps with the FDA.
