Дабрафениб получил статус принципиально нового ЛС в лечении мутировавшего НМРЛ
Пресс-служба GlaxoSmithKline о предоставлении препарату Тафинлар (Tafinlar) статуса принципиально нового лекарственного средства для лечения метастазирующего немелкоклеточного рака легкого (НМРЛ) с мутацией BRAF V600E. В настоящее время Тафинлар нигде в мире не используется для терапии НМРЛ.
Специалисты FDA приняли решение о присвоении статуса принципиального нового ЛС Тафинлару (дабрафениб) после изучения результатов II фазы КИ с участием 25 пациентов, страдающих НМРЛ с мутацией BRAF V600E и уже прошедших курс химиотерапии.
Пероральный препарат дабрафениб является ингибитором BRAF. Он одобрен для лечения пациентов с неоперабельной и метастатической меланомой, опухолевые клетки которой несут мутацию V600E в гене BRAF.
Белок BRAF - часть сигнального пути RAS-RAF, участвующего в регуляции деления клеток. Мутации в кодирующем этот белок гене могут привести к чрезмерно активному делению и злокачественному перерождению клеток.
По данным сайта http://www.remedium.ru/
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