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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 스펙트럼 “’포지오티닙’, FDA 혁신치료제 지정 불발" - 바이오스펙테이터

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스펙트럼 “’포지오티닙’, FDA 혁신치료제 지정 불발"

입력 2018-12-20 08:31 수정 2018-12-20 08:31

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한미가 2015년 수출한 pan-HER 저해제..임상 2상 시판허가 계속 추진

한미약품 파트너사 스펙트럼 파마슈티컬스는 19일(현지시간) "EGFR 엑손20 변이 전이성 비소세포폐암을 적응증으로 하는 포지오티닙에 대한 혁신치료제 지정(Breakthrough Therapy Designation)을 신청했으나 지정받지 못했다"고 밝혔다. 혁신치료제는 생명을 위협하는 중대한 질병의 치료가 기대되는 신약 후보물질을 우선 심사해 2상 임상 결과만으로도 신속히 허가를 부여하는 제도다.

포지오티닙은 한미약품이 2015년 미국 스펙트럼 파마슈티컬에 기술수출한 pan-HER 저해제다. 스펙트럼은 MD앤더슨에서 EGFR 엑손20 변이 전이성 비소세포폐암 환자 30명을 대상으로 연구자 임상 2상 중간결과(객관적 반응률 40%, 중간반응 지속기간 6.6개월)를 토대로 혁신치료제 지정을 신청했다.

스펙트럼의 조 터전 대표는 “현재 진행 중인 스펙트럼 2상(ZENITH20)을 토대로 가장 빠른 허가승인 절차를 FDA와 지속적으로 논의해 나갈 계획”이라며 “포지오티닙에 관한 우리의 개발 일정과 프로그램에는 변화가 없다”고 말했다.

스펙트럼은 이 임상2상 결과를 토대로 곧바로 시판허가를 신청한다는 계획이다. 미국도 한국과 마찬가지로 항암신약 등 치료제가 절실한 분야에서는 임상 2상 결과만으로도 시판허가를 신청할 수 있다. 이 연구를 위한 환자 등록은 내년 1분기에 완료하고, 중간 결과는 내년 하반기 중 발표할 예정이다.

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