Approvals in 2017: gene therapies and site-agnostic indications

Approvals in 2017: gene therapies and site-agnostic indications, Published online: 31 January 2018; doi:10.1038/nrclinonc.2018.11

In 2017, FDA Oncology approved 17 new drug and biologic applications, 32 supplemental drug and biologic applications, and two biosimilar applications in oncology. These actions included landmark approvals of two chimeric antigen receptor T cell therapies and the first site-agnostic, biomarker-defined approval. Three next-generation sequencing 'oncopanels' designed to detect hundreds of somatic genetic aberrations were also approved.

中文翻译：

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2017年获得批准：基因疗法和与地点无关的适应症

2017年获得批准：基因疗法和与地点无关的适应症

2017年批准：基因疗法和与位点无关的适应症，在线发布：2018年1月31日; doi：10.1038 / nrclinonc.2018.11

2017年，FDA肿瘤学批准了17种新药和生物学申请，32种补充药和生物学申请以及两种生物仿制药在肿瘤学中的应用。这些行动包括两种嵌合抗原受体T细胞疗法的里程碑式批准，以及首个与地点无关的生物标记物定义的批准。设计用于检测数百种体细胞遗传畸变的三个下一代测序“ oncopanels”也获得了批准。