The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment
The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment
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DOI：
10.1097/ppo.0000000000000316
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发表时间：
2018-05-01
期刊：
影响因子：
2.2
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Goldberg, Kirsten B.;Blumenthal, Gideon M.;Pazdur, Richard
根据《21世纪世纪治愈法案》的授权，美国食品药品监督管理局于2017年1月正式成立了肿瘤学卓越中心（OCE），以加快某些药物、生物制剂和癌症治疗器械的开发和审查。在第一年，OCE对几种产品进行了临床审查，包括前两种被批准用于治疗晚期血液恶性肿瘤的嵌合抗原受体T细胞疗法和体外诊断下一代测序板FoundationOne CDx。OCE还与专业协会和患者倡导者合作，努力使临床试验资格标准现代化，从而提出了关于最低年龄，脑转移，器官功能障碍和人类免疫缺陷病毒合并感染的建议。2017年，美国食品药品监督管理局批准了16项新药和生物制品申请，30项补充药物和生物制品申请，以及2项肿瘤学生物类似药申请。
The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx. The OCE also worked with professional societies and patient advocates on efforts to modernize clinical trial eligibility criteria, resulting in recommendations regarding minimal age, brain metastases, organ dysfunction, and human immunodeficiency virus coinfection. Altogether in 2017, the Food and Drug Administration approved 16 new drug and biologic applications, 30 supplemental drug and biologic applications, and 2 biosimilar applications in oncology.