Merck's Subcutaneous KEYTRUDA QLEX Approved In Japan For All Existing KEYTRUDA Indications

Merck & Co, Inc. (MRK) announced that the Japanese Ministry of Health, Labour and Welfare has approved its subcutaneous formulation of KEYTRUDA, known as QLEX, for all existing indications of the drug. The approval covers the same indications for which the intravenous formulation of KEYTRUDA is currently authorized in Japan.

The company noted that the approval of the subcutaneous formulation is based on the results of a Phase 3 study comparing the subcutaneous and intravenous formulations of KEYTRUDA. The study demonstrated that the subcutaneous formulation is non-inferior to the intravenous formulation in terms of efficacy and safety.

The subcutaneous formulation of KEYTRUDA is administered via an injection, rather than an intravenous infusion. The company stated that the subcutaneous formulation may offer convenience and potential benefits for patients compared to the intravenous formulation.