By: IPP Bureau
Last updated : November 21, 2025 9:52 am
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
Global pharma giant Merck has announced that the European Commission has approved a new subcutaneous formulation of its blockbuster cancer therapy, KEYTRUDA (pembrolizumab).
The new form, marketed in the EU as KEYTRUDA SC, offers a faster, more convenient injection and expands treatment options for patients across all 33 approved indications in Europe, according to the company, known as MSD outside North America.
KEYTRUDA SC combines pembrolizumab with berahyaluronidase alfa, a human hyaluronidase variant developed by Alteogen Inc., allowing the therapy to be administered under the skin in just one minute every three weeks or two minutes every six weeks. In the US, the therapy is known as KEYTRUDA QLEX.
"This is the first and only subcutaneous immune checkpoint inhibitor available in Europe,” said Dr Marjorie Green, senior VP of oncology at Merck Research Laboratories. “KEYTRUDA SC offers faster administration, flexible dosing, and more options for patients to receive therapy in different healthcare settings.”
The approval is based on the pivotal Phase 3 3475A-D77 trial in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 tumor mutations.
The trial compared KEYTRUDA SC to standard intravenous KEYTRUDA, both combined with chemotherapy. Results showed nearly identical efficacy: overall response rates were 45% for KEYTRUDA SC and 42% for intravenous KEYTRUDA, with no meaningful differences in progression-free or overall survival.
The trial enrolled 377 patients randomized 2:1 to KEYTRUDA SC (790 mg/9,600 units) or KEYTRUDA (400 mg) every six weeks alongside platinum-based chemotherapy. KEYTRUDA SC’s safety profile was consistent with the established intravenous formulation, with the most common adverse reactions being nausea (25%), fatigue (25%), and musculoskeletal pain (21%).
The EU approval covers all 27 member states plus Iceland, Liechtenstein, and Norway. Timing for commercial availability in individual countries will depend on national reimbursement processes.
KEYTRUDA, a humanized monoclonal antibody, works by blocking PD-1 from interacting with its ligands PD-L1 and PD-L2, reactivating T cells to detect and attack tumor cells. The introduction of KEYTRUDA SC represents a patient-focused evolution of one of the world’s leading cancer immunotherapies.