European Commission approves Subcutaneous Administration of KEYTRUDA (pembrolizumab) for All Adult Indications Approved in the European Union
Merck announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.
KEYTRUDA, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications for adult patients in Europe. Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc.
The approval of KEYTRUDA SC is based on results from the pivotal 3475A-D77 trial, which compared KEYTRUDA SC and KEYTRUDA, both administered every six weeks, each in combination with chemotherapy, in patients with treatment naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. This trial demonstrated comparable pharmacokinetic exposure levels between KEYTRUDA SC and KEYTRUDA. In descriptive efficacy analyses, overall response rates (ORR) were consistent between KEYTRUDA SC and KEYTRUDA. The ORR in the KEYTRUDA SC with chemotherapy arm was 45% (95% CI, 39-52) and 42% (95% CI, 33-51) in the KEYTRUDA with chemotherapy arm. Additionally, no notable differences were observed in progression-free survival (PFS) and overall survival (OS).
This decision authorizes the marketing of KEYTRUDA SC in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA SC in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.
The EC approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) received in September 2025. Also in September 2025, KEYTRUDA QLEX was approved by the U.S. Food and Drug Administration (FDA). In the United States, KEYTRUDA QLEX is now approved for use in adults across all solid tumor indications approved for KEYTRUDA.
Subcutaneous administration is a method of delivering medications under the skin, offering faster administration than intravenous infusion. Subcutaneous administration may provide added convenience because it offers more options where patients can receive their treatment because it can be administered by health care providers in multiple settings from an infusion center to a doctor’s office or a local community-based clinic. For patients who do not require a port or whose veins are difficult to access, subcutaneous administration may simplify treatment administration.