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米拉妥昔单抗soravtansine:首次批准。

Mirvetuximab Soravtansine: First Approval.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

Drugs. 2023 Feb;83(3):265-273. doi: 10.1007/s40265-023-01834-3.

DOI:10.1007/s40265-023-01834-3
PMID:36656533
Abstract

Mirvetuximab soravtansine (mirvetuximab soravtansine-gynx; Elahere) is an antibody-drug conjugate (ADC), which is comprised of a folate receptor α (FRα) directed antibody conjugated to a microtubule inhibitor via a cleavable linker. The ADC is being developed by ImmunoGen for the treatment of FRα expressing cancers. In November 2022, mirvetuximab soravtansine was approved in the USA for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens. This article summarizes the milestones in the development of mirvetuximab soravtansine leading to this first approval.

摘要

米拉妥昔单抗soravtansine(米拉妥昔单抗soravtansine-gynx;艾拉雷)是一种抗体药物偶联物(ADC),由叶酸受体α(FRα)定向抗体通过可切割接头与微管抑制剂偶联而成。该 ADC 由 ImmunoGen 开发,用于治疗 FRα 表达的癌症。2022 年 11 月,米拉妥昔单抗 soravtansine 在美国获得批准,用于治疗 FRα 阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者,这些患者已接受过 1-3 种先前的全身治疗方案。本文总结了米拉妥昔单抗 soravtansine 开发过程中的重要里程碑,直至首次获得批准。

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Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I.III 期随机临床试验:索拉非尼单药治疗与化疗用于铂耐药卵巢癌患者的比较:FORWARD I 研究的主要分析。
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A phase II study of Mirvetuximab Soravtansine in triple-negative breast cancer.一项 Mirvetuximab Soravtansine 在三阴性乳腺癌中的 II 期研究。
Invest New Drugs. 2021 Apr;39(2):509-515. doi: 10.1007/s10637-020-00995-2. Epub 2020 Sep 28.
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Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer.
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Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.抗体药物偶联物(ADCs):当前及未来的生物制药
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