European Investor
21 Sep 2026, 19:41
Merck’s KEYTRUDA QLEX Approved in Japan for All KEYTRUDA Indications
Merck said Japan’s Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX for subcutaneous administration across all indications already approved in the country for intravenous KEYTRUDA.
In Japan, the product will be marketed under the planned name KEYJECT. It can be administered by a healthcare provider in about one minute every three weeks or two minutes every six weeks, making it the first and only subcutaneous immune checkpoint inhibitor available in Japan with administration as short as one minute.
The approval was supported by the Phase 3 MK-3475A-D77 study comparing subcutaneous KEYJECT with intravenous KEYTRUDA, both given every six weeks with chemotherapy in previously untreated metastatic non-small cell lung cancer. The study showed comparable pembrolizumab exposure, while response rates were 45% with KEYJECT plus chemotherapy and 42% with KEYTRUDA plus chemotherapy. No notable differences in progression-free or overall survival were observed.
Merck said the subcutaneous formulation could give patients and healthcare providers greater flexibility by allowing treatment in settings ranging from infusion centers to physician offices and community clinics.
KEYTRUDA QLEX is already approved in the U.S. for the same solid-tumor indications as KEYTRUDA, while subcutaneous pembrolizumab was approved in Europe in 2025.
Merck said Japan’s Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX for subcutaneous administration across all indications already approved in the country for intravenous KEYTRUDA.
In Japan, the product will be marketed under the planned name KEYJECT. It can be administered by a healthcare provider in about one minute every three weeks or two minutes every six weeks, making it the first and only subcutaneous immune checkpoint inhibitor available in Japan with administration as short as one minute.
The approval was supported by the Phase 3 MK-3475A-D77 study comparing subcutaneous KEYJECT with intravenous KEYTRUDA, both given every six weeks with chemotherapy in previously untreated metastatic non-small cell lung cancer. The study showed comparable pembrolizumab exposure, while response rates were 45% with KEYJECT plus chemotherapy and 42% with KEYTRUDA plus chemotherapy. No notable differences in progression-free or overall survival were observed.
Merck said the subcutaneous formulation could give patients and healthcare providers greater flexibility by allowing treatment in settings ranging from infusion centers to physician offices and community clinics.
KEYTRUDA QLEX is already approved in the U.S. for the same solid-tumor indications as KEYTRUDA, while subcutaneous pembrolizumab was approved in Europe in 2025.
