Korea MSD, the Korean unit of Merck (MSD), will launch a subcutaneous (SC) formulation of the immunotherapy Keytruda in Korea. The administration time will be significantly reduced compared with the existing intravenous (IV) infusion, improving patient convenience and hospital operational efficiency.
Korea MSD said on Jan. 20 that it has received marketing approval for Keytruda subcutaneous injection from the Ministery of Food and Drug Safety.
The product applies the human hyaluronidase technology (ALT-B4) of Korean biotech company Alteogen and is scheduled to launch domestically in the fourth quarter of this year.
While the existing Keytruda IV infusion took about 30 minutes per administration, the subcutaneous formulation can be given in 1–2 minutes. Assuming patients are treated every three weeks, annual administration time is reduced from about 8 hours 30 minutes to around 17 minutes.
The indications are the same as the existing IV 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 used interchangeably with the existing IV infusion.
Patient preference also came out high. In a phase 2 study, 65% of patients who experienced both the subcutaneous injection and the IV infusion preferred the subcutaneous route. The main reasons cited were shorter hospital stay and a more comfortable administration process.
Efficiency improves for hospitals as well. Patient chair time, treatment room stay, and medical staff work time all fell by nearly half.
Kim Albert, head of Korea MSD, said, "Approval of the Keytruda subcutaneous injection is meaningful in that it reduces patients' treatment burden and allows more efficient use of medical resources."