Approval Overview
The European Commission has approved the subcutaneous administration of KEYTRUDA® (pembrolizumab) for all adult indications in the EU. This marks the first subcutaneous immune checkpoint inhibitor in Europe, allowing administration by healthcare providers in as little as one minute.
Clinical Trial Basis
The approval is based on results from the pivotal 3475A-D77 trial, which compared KEYTRUDA SC and intravenous KEYTRUDA, both administered every six weeks with chemotherapy in patients with treatment-naïve metastatic non-small cell lung cancer. The trial demonstrated comparable pharmacokinetic exposure levels and consistent overall response rates between the two forms.
Administration and Availability
KEYTRUDA SC offers faster administration than the intravenous form, with options for one-minute administration every three weeks or two minutes every six weeks. The decision authorizes marketing in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Commercial availability will depend on national reimbursement procedures.
