Posted by Michael Wonder on 20 Sep 2025
Merck receives two positive EU CHMP opinions for Keytruda (pembrolizumab), for subcutaneous administration and for new indication for earlier-stage head and neck cancer
19 September 2025 - Positive opinion also granted for Keytruda as part of a peri-operative regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma based on results of Phase 3 KEYNOTE-689 trial.
Merck today announced that the EMA’s CHMP adopted two positive opinions for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
One recommends approval of a new subcutaneous route of administration and a new pharmaceutical form (solution for injection) for Keytruda (pembrolizumab), which if approved would be marketed in the European Union as Keytruda SC.
