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키트루다, ‘첫 단일요법 1차' 대장암치료제 FDA 승인 - 바이오스펙테이터

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키트루다, ‘첫 단일요법 1차' 대장암치료제 FDA 승인

입력 2020-06-30 14:11 수정 2020-07-01 08:49

바이오스펙테이터 서윤석 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
절제불가능 또는 전이성 MSI-H/dMMR 대장암 단일요법 1차 치료제..사망위험도 40% 감소, 무진행생존기간(PFS) 유의미하게 개선

미국 머크(MSD)의 ‘키트루다’가 단일요법으로는 처음으로 절제불가능 또는 전이성 MSI-H/dMMR 대장암 1차 치료제로 미국 식품의약국(FDA)의 승인을 받았다.

이번 승인은 전이성 MSI-H/dMMR 대장암을 대상으로 진행한 KEYNOTE-177(NCT02563002) 임상 3상 결과를 바탕으로 이뤄졌다. 머크의 키트루다는 키노트-177 임상 3상에서 MSI-H/dMMR 대장암 환자의 사망위험을 40%(HR: 0.60; 95% CI, 0.45-0.80; p=0.0004) 감소시켰다. 키트루다는 또 화학요법보다 무진행생존기간(PFS)을 16.5개월(vs 8.2개월)로 유의미하게 증가시켰다.

미국 머크는 29일(현지시간) 미국 FDA에서 PD-1 항체 ‘키트루다(Keytruda, pembrolizumab)’를 전이성 MSI-H/dMMR 대장암에 대한 단독요법 1차 치료제로 승인했다고 밝혔다.

미국 국립 암연구소(National Cancer Institute)에 따르면 대장암 환자의 약 15%와 전이성 대장암 환자의 약 4~5%는 MSI-H 또는 dMMR을 바이오 마커로 가지고 있으며, MSI-H/dMMR 대장암 환자는 치료 예후가 좋지 않다....

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