Merck & Co., Inc. (MRK.US) received FDA approval to market its K drug in subcutaneous injection form.

Merck & Co., Inc. (MRK.US) announced that Keytruda QLEX (subcutaneous Keytruda) has been approved by the U.S. FDA for all solid tumor indications previously approved for intravenous Keytruda. In June of this year, the subcutaneous formulation of Keytruda has been submitted for approval in China, with expected approval in the country next year. Data shows that the subcutaneous pembrolizumab offers a flexible dosing option, with the ability to be injected every three weeks for one minute, or every six weeks, significantly reducing the time needed compared to the 30-minute intravenous infusion of pembrolizumab. In November 2024, Merck & Co., Inc. announced successful results for subcutaneous pembrolizumab in the pivotal Phase III study MK-3475A-D77, which aimed to compare subcutaneous pembrolizumab plus chemotherapy with intravenous Keytruda plus chemotherapy in the first-line treatment of adult patients with metastatic non-small cell lung cancer (regardless of PD-L1 TPS expression). In this study, subcutaneous pembrolizumab was injected every six weeks for a median time of 2 minutes, at a volume of 4.8 milliliters per injection.