Merck Gains EU CHMP Support for KEYTRUDA SC and New Head and Neck Cancer Use

CHMP Opinions on KEYTRUDA

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions for Merck's KEYTRUDA (pembrolizumab). One opinion supports a new subcutaneous (SC) administration route for all adult indications in the EU, potentially marketed as KEYTRUDA SC. The other opinion endorses a new indication for treating locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Subcutaneous Administration Details

KEYTRUDA SC, if approved, could be administered in one minute every three weeks (395 mg) or two minutes every six weeks (790 mg). This subcutaneous form includes pembrolizumab and berahyaluronidase alfa, developed by Alteogen Inc. The CHMP's positive opinion applies to all adult indications for KEYTRUDA in Europe.

Clinical Trial Insights

The marketing authorization application for KEYTRUDA SC is based on the pivotal 3475A-D77 trial. This trial compared KEYTRUDA SC and intravenous KEYTRUDA, both with chemotherapy, in patients with metastatic non-small cell lung cancer (NSCLC). The trial showed comparable pharmacokinetic exposure levels and consistent efficacy endpoints between the two forms.

New Indication for Head and Neck Cancer

The second CHMP opinion recommends KEYTRUDA as a monotherapy for resectable LA-HNSCC, used as neoadjuvant and adjuvant treatment. This recommendation is based on the Phase 3 KEYNOTE-689 trial, which demonstrated significant improvement in event-free survival compared to standard adjuvant radiotherapy.

Next Steps

The CHMP recommendations will 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.