Trastuzumab Deruxtecan: First Approval
Trastuzumab Deruxtecan: First Approval
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DOI：
10.1007/s40265-020-01281-4
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发表时间：
2020-04-01
期刊：
影响因子：
11.5
通讯作者：
Keam, Susan J.
中科院分区：
文献类型：
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作者：
Keam, Susan J.
Trastuzumab deruxtecan （ENHERTU (R)）是一种her2导向抗体和DNA拓扑异构酶I抑制剂偶联物，由Daiichi Sankyo Company Ltd与AstraZeneca合作开发，用于治疗表达her2的实体肿瘤，包括乳腺癌、胃癌、结直肠癌和非小细胞肺癌。基于2期DESTINY-Breast01试验的结果，曲妥珠单抗德鲁德康最近在美国获得批准，用于治疗不可切除或转移性her2阳性乳腺癌的成人患者，这些患者在转移性环境中接受过两种或更多基于抗her2的方案。本文总结了曲妥珠单抗德鲁德康首次获批的发展里程碑。
Trastuzumab deruxtecan (ENHERTU (R)), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate, is being developed for the treatment of HER2-expressing solid tumours, including breast cancer, gastric cancer, colorectal cancer and non-small cell lung cancer by Daiichi Sankyo Company Ltd in collaboration with AstraZeneca. Based primarily on the results of the phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan was recently approved in the USA under accelerated approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This article summarizes the milestones in the development of trastuzumab deruxtecan leading to this first approval.