Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.
СтатьяResearch Support, N.I.H., IntramuralНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Sweet Kendra L, Cortes Jorge E, Apperley Jane F, Mann Mel, Mauro Michael J, Oehler Vivian G, Ruiz Cristina, Schiffer Charles A, Ehrlich Lori A, Pamuk Gulsum E, Wynne Joseph, Mehta Gautam U, de Claro R Angelo, Theoret Marc R, Smith B Douglas, Norsworthy Kelly J
Аннотация
The FDA has an accelerated approval program for drugs that have been identified as promising treatments for serious conditions when the available data suggest that the benefits outweigh the foreseeable risks. All of the currently available treatment options for chronic myeloid leukemia (CML) initially went through the accelerated approval program. Here, a group of academic CML experts, patient panelists, and members from the FDA convened to discuss the utility of the accelerated approval program as it pertains to CML, and the utility of this program in future drug development in this disease. The results of that discussion are summarized here.