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MSD Korea to launch subcutaneous Keytruda in October
한국MSD (MSD Korea) has announced the official launch of the subcutaneous (SC) formulation of the anti-PD-1 immunotherapy Keytruda in South Korea, with supply beginning on October 1. The new formulation is applicable to 35 indications across 18 types of cancer, including lung, gastric, and triple-negative breast cancer.
Utilizing Alteogen’s ‘berahyaluronidase alfa’ to enable large-volume administration, the SC version significantly reduces treatment time. While the standard intravenous (IV) dose takes approximately 30 minutes, the SC dose requires only about 1 minute (for 3-week intervals) or 2 minutes (for 6-week intervals), resulting in a 96.7% reduction in annual administration time.
Clinical studies support the transition. A Phase 3 study (MK-3475A-D77) confirmed the SC formulation's non-inferiority in drug exposure compared to the IV version, with a similar safety profile. Additionally, a Phase 2 crossover study showed that 65% of patients preferred the SC formulation due to shorter hospital stays and increased comfort. Observational data also indicated that the SC formulation reduces patient chair time by 50% and medical staff workload by 45.6%. The new formulation allows for cross-administration with the existing IV version.
Entities
Alteogen · Keytruda · Lee Hee-seung · MSD · South Korea
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] The product utilizes Alteogen’s ‘berahyaluronidase alfa’ to enable large-volume subcutaneous administration. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] The subcutaneous formulation can be used for 35 indications across 18 types of cancer, including lung, gastric, and triple-negative breast cancer. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 2 SOURCES] The subcutaneous formulation allows for cross-administration with the existing intravenous formulation. www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] Observational data showed that medical staff workload time decreased by 45.6% when using the subcutaneous formulation. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] In a Phase 2 crossover study, 65% of patients who experienced both formulations preferred the subcutaneous version. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] The subcutaneous formulation reduces annual administration time by approximately 96.7% compared to the intravenous formulation. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] 한국MSD is officially launching the subcutaneous formulation of the anti-PD-1 immunotherapy Keytruda in South Korea in October. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com
- [● 3 SOURCES] A Phase 3 clinical study demonstrated that the subcutaneous formulation met non-inferiority criteria regarding drug exposure compared to the intravenous version. www.healthmedia.co.kr · www.thebionews.net · www.bokuennews.com