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达雷那布林:首次获批。

Darinaparsin: First Approval.

机构信息

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

出版信息

Drugs. 2022 Nov;82(16):1603-1609. doi: 10.1007/s40265-022-01795-z.

DOI:10.1007/s40265-022-01795-z
PMID:36331780
Abstract

Darinaparsin (Darvias), an organoarsenic drug, is a novel mitochondrial-targeted anticancer agent currently being developed by Solasia Pharma K.K for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). An intravenous formulation of darinaparsin has been approved for the treatment of relapsed or refractory PTCL in Japan, and preparation for the next stage of the clinical development program for this indication is currently underway in China, the USA and the EU. This article summarizes the milestones in the development of darinaparsin leading to this first approval for relapsed or refractory PTCL.

摘要

达尼泊司他(达维巴嗪),一种有机砷药物,是一种新型的靶向线粒体的抗癌药物,目前由 Solasia Pharma K.K 公司开发,用于治疗复发或难治性外周 T 细胞淋巴瘤(PTCL)。达尼泊司他的静脉制剂已在日本获批用于治疗复发或难治性 PTCL,目前正在中国、美国和欧盟为该适应症的下一阶段临床开发计划做准备。本文总结了达尼泊司他开发过程中的重要里程碑,这些里程碑促成了该药在复发或难治性 PTCL 中的首次获批。

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Darinaparsin: First Approval.达雷那布林:首次获批。
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2
[Pharmacological profile and clinical study results of darinaparsin (DARVIAS injection 135 ‍mg), an organic arsenic product, for relapsed or refractory peripheral t-cell lymphoma].有机砷产品达利珠单抗(135毫克注射用达利珠单抗)用于复发或难治性外周T细胞淋巴瘤的药理学特征及临床研究结果
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本文引用的文献

1
Guidelines for the management of mature T- and natural killer-cell lymphomas (excluding cutaneous T-cell lymphoma): a British Society for Haematology Guideline.成熟T细胞和自然杀伤细胞淋巴瘤(不包括皮肤T细胞淋巴瘤)管理指南:英国血液学学会指南
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Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea.在日本和韩国进行的两项 I 期研究的汇总分析:复发或难治性外周 T 细胞淋巴瘤患者中达那帕利森的 I 期研究。
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Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.靶向“不可成药”蛋白的最新进展:从药物发现到临床试验。
Signal Transduct Target Ther. 2023 Sep 6;8(1):335. doi: 10.1038/s41392-023-01589-z.
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Hedgehog signaling in tissue homeostasis, cancers, and targeted therapies.刺猬信号通路在组织稳态、癌症和靶向治疗中的作用。
Signal Transduct Target Ther. 2023 Aug 18;8(1):315. doi: 10.1038/s41392-023-01559-5.
6
Targeting Mitochondrial Metabolic Reprogramming as a Potential Approach for Cancer Therapy.靶向线粒体代谢重编程作为一种潜在的癌症治疗方法。
Int J Mol Sci. 2023 Mar 4;24(5):4954. doi: 10.3390/ijms24054954.
Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry.
一线治疗后的复发/难治性外周 T 细胞淋巴瘤患者的 COMPLETE 登记研究结果。
Acta Haematol. 2020;143(1):40-50. doi: 10.1159/000500666. Epub 2019 Jul 17.
4
Metabolism, toxicity and anticancer activities of arsenic compounds.砷化合物的代谢、毒性及抗癌活性
Oncotarget. 2017 Apr 4;8(14):23905-23926. doi: 10.18632/oncotarget.14733.
5
The novel organic arsenical darinaparsin induces MAPK-mediated and SHP1-dependent cell death in T-cell lymphoma and Hodgkin lymphoma cells and human xenograft models.新型有机砷化合物达里纳帕林在T细胞淋巴瘤、霍奇金淋巴瘤细胞及人异种移植模型中可诱导丝裂原活化蛋白激酶(MAPK)介导的及含Src同源2结构域蛋白酪氨酸磷酸酶1(SHP1)依赖性细胞死亡。
Clin Cancer Res. 2014 Dec 1;20(23):6023-33. doi: 10.1158/1078-0432.CCR-14-1532. Epub 2014 Oct 14.
6
The novel arsenical darinaparsin is transported by cystine importing systems.新型砷剂达林那帕司他通过胱氨酸输入系统转运。
Mol Pharmacol. 2014 Apr;85(4):576-85. doi: 10.1124/mol.113.089433. Epub 2014 Jan 15.
7
Darinaparsin is a multivalent chemotherapeutic which induces incomplete stress response with disruption of microtubules and Shh signaling.达瑞那布林是一种多价化疗药物,它通过破坏微管和 Shh 信号诱导不完全应激反应。
PLoS One. 2011;6(11):e27699. doi: 10.1371/journal.pone.0027699. Epub 2011 Nov 15.
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A multicenter phase II study of darinaparsin in relapsed or refractory Hodgkin's and non-Hodgkin's lymphoma.达瑞木单抗治疗复发或难治性霍奇金淋巴瘤和非霍奇金淋巴瘤的多中心II期研究。
Am J Hematol. 2012 Jan;87(1):111-4. doi: 10.1002/ajh.22232. Epub 2011 Nov 12.
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Darinaparsin: a novel organic arsenical with promising anticancer activity.达利那帕辛:一种具有良好抗癌活性的新型有机砷剂。
Expert Opin Investig Drugs. 2009 Nov;18(11):1727-34. doi: 10.1517/13543780903282759.
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A phase I clinical trial of darinaparsin in patients with refractory solid tumors.达瑞木单抗治疗难治性实体瘤患者的I期临床试验。
Clin Cancer Res. 2009 Jul 15;15(14):4769-76. doi: 10.1158/1078-0432.CCR-08-2984. Epub 2009 Jul 7.