Merck's KEYTRUDA QLEX Wins Japan Approval for Subcutaneous Use

Merck & Co. (MRK) said on Sept. 21, 2026, that Japan's Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous administration. The approval covers the subcutaneous formulation of Merck's flagship oncology drug, offering an alternative to intravenous infusion. KEYTRUDA is Merck's top-selling product and a major revenue driver. Financial terms and pricing details were not disclosed. The company did not specify an expected launch date or the indications covered by the Japanese approval.