Development trends for human monoclonal antibody therapeutics
Development trends for human monoclonal antibody therapeutics
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DOI：
10.1038/nrd3229
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发表时间：
2010-10-01
影响因子：
120.1
通讯作者：
Reichert, Janice M.
中科院分区：
文献类型：
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作者：
Nelson, Aaron L.;Dhimolea, Eugen;Reichert, Janice M.
全人单克隆抗体（mAb）是一种有前途的和快速增长的靶向治疗剂的类别。第一批此类药物是在20世纪80年代开发的，但没有一个获得临床或商业成功。在20世纪90年代，产生研究分子的技术进步-特别是转基因小鼠和酵母或噬菌体展示-重新引起了人们对开发人类单克隆抗体的兴趣。2002年，阿达木单抗成为美国食品药品监督管理局（FDA）批准的第一个人源mAb。从那时起，另外六种人mAb获得了FDA批准：帕尼单抗，戈利木单抗，卡那单抗，优特克单抗，奥法木单抗和狄诺塞单抗。此外，3种候选药物（raxibacumab，belimumab和ipilimumab）目前正在接受FDA的审查，7种处于III期研究，81种处于I期或II期研究。在这里，我们分析了已进入临床研究的147种人类mAb的数据，以突出其开发和批准的趋势，这可能有助于为这类治疗药物的未来研究提供信息。
Fully human monoclonal antibodies (mAbs) are a promising and rapidly growing category of targeted therapeutic agents. The first such agents were developed during the 1980s, but none achieved clinical or commercial success. Advances in technology to generate the molecules for study - in particular, transgenic mice and yeast or phage display-renewed interest in the development of human mAbs during the 1990s. In 2002, adalimumab became the first human mAb to be approved by the US Food and Drug Administration (FDA). Since then, an additional six human mAbs have received FDA approval: panitumumab, golimumab, canakinumab, ustekinumab, ofatumumab and denosumab. In addition, 3 candidates (raxibacumab, belimumab and ipilimumab) are currently under review by the FDA, 7 are in Phase III studies and 81 are in either Phase I or II studies. Here, we analyse data on 147 human mAbs that have entered clinical study to highlight trends in their development and approval, which may help inform future studies of this class of therapeutic agents.