Japan’s Ministry of Health, Labour and Welfare approved Merck’s KEYTRUDA QLEX for subcutaneous injection across all existing indications. The formulation will be marketed as KEYJECT in Japan. It combines pembrolizumab with a delivery-enhancing substance.
The new injection reduces administration time to between one and two minutes. This compares to 30 to 60 minutes for traditional intravenous infusions.
A Phase 3 study confirmed the subcutaneous version offers comparable efficacy and safety to the intravenous form in lung cancer patients.
The faster formulation supports Merck’s strategy to defend its market position against future biosimilar competition. The subcutaneous version received U.S. and European approvals in 2025.