Merck(US:MRK) Zhi Tong Cai Jing·2025-09-20 12:54Core Insights - Merck (MRK.US) announced that Keytruda QLEX (subcutaneous Keytruda) has received FDA approval for all previously approved indications for intravenous Keytruda in solid tumors [1] - The subcutaneous formulation of pembrolizumab has been submitted for approval in China, with expectations for approval next year [1] - The subcutaneous administration offers a flexible treatment option, allowing for injections every three weeks in one minute or every six weeks, significantly reducing the time compared to the 30-minute intravenous infusion [1] Study Results - In November 2024, Merck reported successful results from the pivotal Phase III study MK-3475A-D77, comparing subcutaneous pembrolizumab plus chemotherapy to intravenous Keytruda plus chemotherapy for first-line treatment in adult patients with metastatic non-small cell lung cancer, regardless of PD-L1 TPS expression [1] - In this study, subcutaneous pembrolizumab was administered every six weeks, with a median injection time of two minutes and a volume of 4.8 milliliters per injection [1]