Merck Wins Japan Approval for Subcutaneous KEYTRUDA QLEX

Merck (MRK) said Japan's Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX, a subcutaneous formulation of its anti-PD-1 therapy KEYTRUDA, for all indications already cleared in the country. The approval covers the subcutaneous injection across KEYTRUDA's existing Japanese label, extending the franchise beyond intravenous administration. Merck said subcutaneous dosing is designed to offer patients and providers a faster administration option relative to infusion. The company did not disclose pricing or a launch date for the Japanese market. Japan is a key oncology market for Merck, whose KEYTRUDA franchise is its largest revenue driver. The approval adds a new delivery format to the drugmaker's immuno-oncology portfolio in the region.