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Drugs. 2015 Feb;75(3):321-7. doi: 10.1007/s40265-015-0356-3.
Blinatumomab (BLINCYTO™) is a novel, bispecific T-cell engaging antibody that binds cluster of differentiation (CD) 19 antigens on blast cells while also binding and activating the CD3/T cell receptor complex, causing cell lysis. The antibody is being developed by Amgen as a treatment for haematological cancers that originate from B cell lines. Blinatumomab was approved by the US FDA in December 2014 for the treatment of adults with Philadelphia chromosome (Ph)-negative relapsed/refractory B-cell precursor acute lymphoblastic leukaemia (BCP-ALL). It is awaiting approval for this indication in the EU and is in phase III development in various countries. This article summarizes the milestones in the development of blinatumomab leading to its first approval for the treatment of Ph-negative BCP-ALL.
Blinatumomab（BLINCYTO™）是一种新型双特异性 T 细胞衔接抗体，能与母细胞表面的分化抗原（CD）19 结合，同时与 CD3/T 细胞受体复合物结合并激活该复合物，导致细胞溶解。该药由安进（Amgen）公司研发，用于治疗起源于 B 细胞系的血液系统恶性肿瘤。Blinatumomab 于 2014 年 12 月获美国食品药品监督管理局（FDA）批准用于治疗费城染色体（Ph）阴性复发性/难治性 B 细胞前体急性淋巴细胞白血病（BCP-ALL）成人患者。该药目前正在欧盟等待该适应证的批准，并且在多个国家处于 III 期临床开发阶段。本文总结了促使blinatumomab 首次获批用于治疗 Ph 阴性 BCP-ALL 的关键研发进展。
