Scot Ebbinghaus, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a new extended dosing schedule for pembrolizumab (Keytruda) for all of the PD-1 inhibitor’s monotherapy indications in the European Union.1
The recommendation supports a new suggested dose of single-agent pembrolizumab at 400 mg every 6 weeks delivered as an intravenous (IV) infusion over 30 minutes. If approved by the European Commission, the every-6-weeks dose would be available in addition to the currently indicated dose of 200 mg every 3 weeks that is infused over 30 minutes.
The European Commission will now review the CHMP’s opinion, and a final decision on a marketing authorization is expected in the second quarter of 2019, according to Merck, the developer of the checkpoint inhibitor.
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