Health
European Commission Approves Subcutaneous Administration of KEYTRUDA® (pembrolizumab) for All Adult Indications Approved in the European Union
RAHWAY, N.J., November 19, 2025--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today 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 SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.]
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/68cd651591fdc81478a19589b3fb0cef"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/rTzybMoiWDl1zml.2XQA_w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/68cd651591fdc81478a19589b3fb0cef","width":480,"height":217}},"lazy":false},{"type":"text","content":"This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute","length":174,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J., November 19, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today 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 SC™, 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. For a list of select indications for which KEYTRUDA and KEYTRUDA QLEX are approved in the United States, see Selected Indications in the U.S. below.","length":945,"tagName":"p"},{"type":"text","content":""We are honored to introduce KEYTRUDA SC, the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered in one minute every three weeks or in two minutes every six weeks," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We are committed to discovering patient-focused innovations for people with cancer like KEYTRUDA SC, which offers faster administration than KEYTRUDA, two dosing options and allows patients more choices of health care settings where they can receive therapy."","lengt...