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제넨텍, 간암 대상 '티쎈트릭+아바스틴 병용' FDA 승인 - 바이오스펙테이터

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제넨텍, 간암 대상 '티쎈트릭+아바스틴 병용' FDA 승인

입력 2020-06-01 13:56 수정 2020-06-03 14:43

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
절제 불가능하거나 진행성 간세포암(HCC) 환자 대상 표준치료제 '넥사바' 대비 OS 및 PFS 개선한 결과 기반.."호주, 캐나다, 싱가포르에도 품목허가 신청서 제출 상태"

'티쎈트릭(Tecentriq, 성분명: atezolizumab)'과 '아바스틴(Avastin, 성분명: bevacizumab)'을 병용하는 치료법이 간세포암 환자의 치료제로 미국 식품의약국(FDA)의 승인을 받았다.

로슈 자회사 제넨텍(Genentech)은 지난달 29일(현지시간) 이전에 전신치료(systemic therapy)를 받은 경험이 없는 전이성 또는 절제불가능한 간세포암(HCC) 환자의 치료제로 면역항암제 ‘티쎈트릭’과 신생혈관 저해제 ‘아바스틴’을 병용하는 치료법을 FDA로부터 승인받았다고 발표했다.

간암 표준치료제인 바이엘(Bayer)의 ‘넥사바(Nexavar, 성분명: sorafenib)’ 대비 환자의 생존기간을 유의미하게 개선한 IMbrave150 임상3상(NCT03434379) 결과에 기반해 내려진 결정이다.

제넨텍은 지난해 10월 IMbrave150 3상 결과를 발표한 바 있다. 임상 결과는 올해 3월 국제학술지 ‘NEJM(New England Journal of Medicine)’에도 공개됐다. 당시 넥사바가 간암 환자의 표준 치료제로 10년 넘게 처방된 가운데, 면역항암제가 절제불가능하거나 전이성을 보이는 간세포암 환자의 전체 생존기간(OS) 및 무진행생존기간(PFS)을 넥사바 대비 유의미하게 개선한 첫 임상3상 결과라는 점에 주목을 받았다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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