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Warning: mysql_real_escape_string(): Access denied for user 'apache'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_query(): Access denied for user 'apache'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531 "첫 FGFR 인산화효소 저해제" 얀센 ‘발버사’, FDA 승인 - 바이오스펙테이터

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"첫 FGFR 인산화효소 저해제" 얀센 ‘발버사’, FDA 승인

입력 2019-04-16 06:35 수정 2019-04-16 17:10

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
임상 2상에서 확인한 전체반응률(32.2%) 결과로 신속승인..FDA가 함께 승인한 동반진단기기 ‘테라스크린(Therascreen)’으로 선별된 FGFR 변이 환자에게 처방할 예정

미국 식품의약국(FDA)이 진행성 또는 전이성 방광암 성인환자의 치료제로 얀센의 '발버사(Balversa, 성분명: Erdafitinib)'를 지난 12일 신속 승인했다. 이에 따라 발버사는 FDA로부터 승인받은 첫 FGFR(Fibroblast growth factor receptor) 인산화효소 저해제가 됐다.

발버사는 FGFR3 또는 FGFR2 변이를 보유하며, 수술 전 보조요법(neoadjuvant) 또는 수술 후 보조요법(adjuvant)으로 12개월 이내에 백금 기반의 화학항암제로 치료 중이거나 치료받은 후에도 증상이 진행된 국소부위 진행성 또는 전이성 요로상피세포암(UC) 성인 환자에게 처방될 예정이다. 판매 가격은 아직 알려지지 않았다.

요로상피세포암은 가장 흔하게 나타나는 형태의 방광암의 일종으로, 모든 방광암의 90% 이상을 차지한다. 요로상피세포암 환자 5명 중 1명이 FGFR 유전자 변이를 가지고 있는 것으로 알려져 있다. FGFR 유전자 변이는 종양 세포가 생존하고 성장할 수 있도록 유도할 수 있다.

이번 FDA 승인은 BLC2001 임상 2상(NCT02365597) 결과를 기반으로 신속 승인됐다. 임상은 FGFR3 유전자 변이형(R248C, S249C, G370C, Y373C)이나 FGFR 융합 유전자 변이형(FGFR3-TACC3, FGFR3-BAIAP2L1, FGFR2-BICC1, FGFR2-CASP7)을 1개 이상 보유하고, 화학항암제로 최소 1회 이상 치료 중이거나 치료 후에도 증상이 진행된 환자 87명을 대상으로 했다. 이 중 4분의 1은 이전에 표준 치료제로 항 PD-1/PD-L1 치료받은 경험이 있는 환자였다. 임상 결과, FGFR2/FGFR3 양성의 국소부위 진행성 또는 전이성 방광암 환자의 전체반응률(ORR)은 완전반응률(2.3%), 부분반응률(29.9%)을 포함해 32.2%로 확인됐다. 발버사의 반응지속기간(Duration of Response, DOR) 중간값은 5.4개월로 나타났다. 발버사에 반응을 보인 환자 중에는 항 PD-1/PD-L1 치료에 반응을 보이지 않은 환자도 있었다....

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