Posted by Michael Wonder on 09 Jul 2019
FDA accepts Merck’s supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule for melanoma and multiple other indications
9 July 2019 - Merck today announced that the U.S. FDA has accepted for review six supplemental biologics license applications 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, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma. If approved by the FDA, the Q6W dose would be available for use in adults in addition to the currently approved dose of Keytruda 200 mg every three weeks (Q3W) infused over 30 minutes.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 18 February 2020.
