Two positive opinions in the EU for Merck's Keytruda

Published: 2025-09-19 07:59:24 ET MRK

Published on 09/19/2025 at 07:59 am EDT

Merck (MSD outside the US and Canada) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted two positive opinions for Keytruda (pembrolizumab), its anti-PD-1 treatment.The first opinion recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (injectable solution) for all approved adult indications of Keytruda in the European Union.The other recommends approval as part of a perioperative regimen to treat certain adult patients with locally advanced resectable squamous cell carcinoma of the head and neck, based on the results of the phase 3 KEYNOTE-689 trial.These recommendations will now be reviewed by the European Commission for marketing authorization in the EU, Iceland, Liechtenstein, and Norway, with final decisions expected in the fourth quarter of 2025.