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吉妥单抗奥唑米星的最新研究与未来前景:它能否卷土重来?

Recent research and future prospects for gemtuzumab ozogamicin: could it make a comeback?

作者信息

O'Hear Carol, Rubnitz Jeffrey E

机构信息

Department of Oncology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Mail Stop 260, Memphis, TN 38105-2794, USA.

出版信息

Expert Rev Hematol. 2014 Aug;7(4):427-9. doi: 10.1586/17474086.2014.924849. Epub 2014 May 29.

DOI:10.1586/17474086.2014.924849
PMID:24871925
Abstract

Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to calicheamicin, was initially granted accelerated US FDA approval for the treatment of acute myeloid leukemia (AML), but was later voluntarily withdrawn from the market because of increased toxicity and lack of benefit in a Phase III clinical trial. However, subsequently published clinical trials that compared standard chemotherapy to chemotherapy plus GO in children and adults with AML demonstrated clinical benefit of GO in certain subgroups of patients, leading to renewed interest in GO. Although the re-emergence of GO into the clinic is uncertain, these results validate the use of CD33 as a target for AML therapy. Much research is underway to develop novel anti-CD33 therapeutics that may be able to pick up where GO left off.

摘要

吉妥珠单抗奥唑米星(GO)是一种与卡奇霉素偶联的人源化抗CD33单克隆抗体,最初获得美国食品药品监督管理局(FDA)加速批准用于治疗急性髓系白血病(AML),但后来由于毒性增加且在一项III期临床试验中未显示出益处而自愿退出市场。然而,随后发表的将标准化疗与化疗联合GO用于儿童和成人AML患者的临床试验表明,GO在某些亚组患者中具有临床益处,这使得人们对GO重新产生兴趣。尽管GO能否重新进入临床尚不确定,但这些结果证实了将CD33作为AML治疗靶点的有效性。目前正在进行大量研究,以开发可能能够延续GO未竟事业的新型抗CD33疗法。

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