Merck receives two positive EU CHMP opinions for Keytruda

Merck (MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted two positive opinions for Keytruda, Merck’s anti-PD-1 therapy. One recommends approval of a new subcutaneous route of administration and a new pharmaceutical form for Keytruda, which if approved would be marketed in the European Union as Keytruda SC. The other positive opinion recommends approval of a new indication in locally advanced head and neck squamous cell carcinoma. The CHMP recommendations will now be reviewed by the European Commission for marketing authorization in the EU, Iceland, Liechtenstein and Norway, and final decisions are expected in the fourth quarter of 2025.