MSD K.K.

Japan Approves Subcutaneous Pembrolizumab, First Subcutaneous Checkpoint Inhibitor in the Country

- Japan's Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX, a fixed-dose combination of pembrolizumab and berahyaluronidase alfa, for subcutaneous use across all 22 approved KEYTRUDA indications. - The product, to be marketed in Japan as KEYJECT, can be given by a healthcare provider in one minute every three weeks or two minutes every six weeks. - Approval was based on the Phase 3 MK-3475A-D77 trial, which showed comparable pembrolizumab exposure and an objective response rate of 45.4% versus 42.1% for intravenous KEYTRUDA. - Merck said KEYJECT is the first and only subcutaneous immune checkpoint inhibitor available in Japan, adding to prior U.S. and European Union approvals of subcutaneous pembrolizumab.