Korea MSD, the Korean subsidiary of Merck (MSD) in the United States, is launching the subcutaneous (SC) formulation of the immunotherapy Keytruda in Korea. Administration time will be greatly reduced compared with the existing intravenous (IV) infusion, improving patient convenience and hospital operational efficiency.
Korea MSD said on the 20th that it received marketing approval for Keytruda subcutaneous injection from the Ministery of Food and Drug Safety.
The product uses Alteogen's human hyaluronidase technology (ALT-B4) from the Korean biotech company, and it is scheduled to be launched domestically in the fourth quarter of this year.
While a single administration of the existing Keytruda intravenous infusion took about 30 minutes, the subcutaneous formulation can be administered in 1–2 minutes. Assuming patients are treated every three weeks, the annual administration time would be reduced from about 8 hours 30 minutes to around 17 minutes.
The indications are the same as the existing intravenous infusion. It can be used for patients with 18 cancer types, including lung cancer, triple-negative breast cancer, gastric cancer and endometrial cancer, and it can be alternated with the existing intravenous infusion.
Patient preference was also high. In a phase 2 clinical trial, 65% of patients who experienced both the subcutaneous and intravenous routes preferred the subcutaneous route. Shorter time spent in the hospital and a more comfortable administration process were cited as the main reasons.
Efficiency also improves from the hospital's perspective. Patient chair time, time spent in the treatment room, and medical staff working time all decreased by nearly half.
Kim Albert, head of Korea MSD, said, "The approval of Keytruda subcutaneous injection is meaningful in that it reduces patients' treatment burden and allows more efficient use of medical resources."