Japan Approves Merck's Subcutaneous KEYTRUDA QLEX for All Indications

Merck's KEYTRUDA QLEX has been approved in Japan for subcutaneous administration for all KEYTRUDA indications. This approval marks a significant milestone for patients and healthcare providers in Japan, offering more convenience and options for treatment.

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute. The approval was based on results from the pivotal Phase 3 MK-3475A-D77 trial, which demonstrated comparable pharmacokinetic exposure levels between KEYJECT and KEYTRUDA.

The trial also showed consistent overall response rates between KEYJECT and KEYTRUDA, with no notable differences in progression-free survival or overall survival observed. This approval is a significant step forward for patients in Japan who can now receive treatment in various healthcare settings, from infusion centers to doctor's offices or local community-based clinics.