Merck: CHMP recommends approval for new dosing schedule for Keytruda

Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended the approval of a new extended dosing schedule for Keytruda, Merck’s anti-PD-1 therapy, for all approved monotherapy indications in the European Union, or EU. In the EU, Keytruda as monotherapy is currently approved for eight indications across five tumor types. The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks delivered as an intravenous infusion over 30 minutes for Keytruda monotherapy. If approved by the European Commission, the new 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 authorization in the EU, and a final decision is expected in Q2.

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