Posted by Michael Wonder on 04 Mar 2019
European Medicines Agency adopts positive opinion for Merck’s Keytruda (pembrolizumab) for six-week dosing schedule across all current monotherapy indications
4 March 2019 - Merck today announced that the CHMP of the EMA has recommended the approval of a new extended dosing schedule for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for all approved monotherapy indications in the European Union.
In the EU, Keytruda as monotherapy is currently approved for eight indications across five tumour types.
The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks (Q6W) delivered as an intravenous infusion over 30 minutes for Keytruda monotherapy. If approved by the European Commission, the Q6W dose would be available in addition to the currently approved dose of Keytruda 200 mg every three weeks infused over 30 minutes. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the EU, and a final decision is expected in the second quarter of 2019.
