FDA присвоило статус Fast Track препарату для лечения рецидивирующего хронического лимфолейкоза
FDA предоставило ускоренное одобрение препарату BGB-16673, разработанному китайской биофармацевтической компанией, для лечения взрослых пациентов с рецидивирующим или рефрактерным хроническим лимфолейкозом (CLL), а также мелкоклеточной лимфоцитарной лимфомой (SLL).
Препарат BGB-16673 предназначен для пациентов, которые ранее проходили минимум две линии терапии, включая ингибиторы тирозинкиназы Брутона (BTKi) и ингибиторы В-клеточной лимфомы 2 (BCL2). Это пероральное средство, направленное на активацию и деградацию тирозинкиназы Брутона (BTK) через химерное соединение CDAC.
Результаты текущего исследования фазы I/II на людях показали, что BGB-16673 имеет приемлемый профиль безопасности и демонстрирует многообещающую эффективность у пациентов с ранее интенсивно леченой CLL/SLL. В рамках глобальной программы клинической разработки BGB-16673 прошли лечение более 300 пациентов из 15 стран.
BGB-16673 разработан для индукции деградации и нормальных, и множественных мутантных форм BTK, включая те мутации, которые обычно вызывают устойчивость к ингибиторам BTK у пациентов с прогрессирующим заболеванием.
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