关键词: FDA accelerated approval Targeted therapy clinical trials Withdrawn drug approvals

Mesh : United States United States Food and Drug Administration Humans Drug Approval Antineoplastic Agents / therapeutic use Neoplasms / drug therapy Medical Oncology / methods Clinical Trials as Topic

来  源:   DOI:10.1016/j.lfs.2024.122615

Abstract:
Launched in 1992, the FDA accelerated approval program grants drugs indicated in rare/life threatening diseases the ability to be marketed at a faster pace than through the traditional track. Each manufacturing company presents its drug to the FDA, and within 60 days it will determine if the drug is eligible for this path. Many drugs that were initially approved through this route, subsequently did not demonstrate their clinical benefits. With cancer being a leading cause of death, a vast majority of drugs that have been approved/withdrawn from this pathway are indicated within oncology. There are a wide variety of cancer subtypes and therapeutic target sites that these drugs have been evaluated for. Herein, is an overview of the 17 oncology drugs, spanning 22 cancer-related indications, that had been approved within the accelerated route and subsequently withdrawn.
摘要:
FDA于1992年启动,加速批准计划授予在罕见/危及生命的疾病中表明的药物以比传统轨道更快的速度销售的能力。每家制造公司都向FDA提交其药物,并在60天内确定该药物是否符合此路径。许多最初通过这种途径获得批准的药物,随后未证明其临床获益.癌症是导致死亡的主要原因,绝大多数已被批准/退出该途径的药物都在肿瘤学范围内。有各种各样的癌症亚型和治疗靶位点,这些药物已经被评估。在这里,是17种肿瘤药物的概述,跨越22个癌症相关的适应症,已在加速路线内获得批准,随后撤回。
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