Merck gets 2 positive opinions from CHMP for Keytruda

MERCK, known as MSD outside of the US and Canada, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for Keytruda (pembrolizumab), Merck's anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for Keytruda (pembrolizumab), which if approved would be marketed in the European Union (EU) as Keytruda SC.

- Rahway, New Jersey

The other positive opinion recommends approval of a new indication in locally advanced head and neck squamous cell carcinoma (LA-HN-SCC). The CHMP recommendations will now be reviewed by the European Commission (EC) for marketing authorization in the EU, Iceland, Liechtenstein and Norway, and final decisions are expected in the fourth quarter of 2025.