Inotuzumab Ozogamicin: First Global Approval
Inotuzumab Ozogamicin: First Global Approval
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DOI：
10.1007/s40265-017-0802-5
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发表时间：
2017-09-01
期刊：
影响因子：
11.5
通讯作者：
Lamb, Yvette N.
中科院分区：
文献类型：
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作者：
Lamb, Yvette N.
静脉注射 inotuzumab ozogamicin（Besponsa (R)；辉瑞）是一种抗 CD22 单克隆抗体-加利车霉素缀合物，可与表达 CD22 的肿瘤细胞结合。结合后，复合物被内化，细胞毒性加利车霉素衍生物在细胞内释放，诱导双链 DNA 断裂和随后的细胞死亡。 2017 年 6 月，EMA 批准inotuzumab ozogamicin 作为单一疗法用于治疗成人复发性或难治性 CD22 阳性 B 细胞前体急性淋巴细胞白血病 (ALL)。伊珠单抗奥佐米星在费城染色体阳性、复发性或难治性 CD22 阳性 B 细胞前体 ALL 成年患者中的使用仅限于至少一种酪氨酸激酶抑制剂治疗失败的患者。 Inotuzumab ozogamicin 于 2017 年 2 月获得美国 FDA 优先审评，用于治疗复发或难治性 B 细胞前体 ALL。在美国，一项评估 inotuzumab ozogamicin 与一线化疗联合治疗新诊断 B 细胞 ALL 成人的 III 期试验最近已启动，inotuzumab ozogamicin 正在进行儿童 CD22 阳性 B 细胞 ALL 的 II 期评估。 Inotuzumab ozogamicin 联合疗法也在 ALL 和慢性粒细胞白血病的 I/II 或 II 期环境以及伯基特淋巴瘤的 I 期环境中进行评估。本文总结了伊珠单抗奥佐米星 (inotuzumab ozogamicin) 开发的里程碑，该里程碑导致首次批准用于 ALL。
Intravenous inotuzumab ozogamicin (Besponsa (R); Pfizer) is an anti-CD22 monoclonal antibody-calicheamicin conjugate that binds to CD22-expressing tumour cells. Upon binding, the complex is internalised and the cytotoxic calicheamicin derivative is released inside the cell, inducing double-strand DNA breakage and subsequent cell death. In June 2017, the EMA granted inotuzumab ozogamicin approval as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). The use of inotuzumab ozogamicin in adult patients with Philadelphia chromosome-positive, relapsed or refractory CD22-positive B-cell precursor ALL is restricted to those who have failed treatment with at least one tyrosine kinase inhibitor. Inotuzumab ozogamicin was granted priority review for the treatment of relapsed or refractory B-cell precursor ALL by the US FDA in February 2017. In the USA, a phase III trial evaluating inotuzumab ozogamicin in combination with frontline chemotherapy in adults with newly diagnosed B-cell ALL has recently been initiated and inotuzumab ozogamicin is under phase II evaluation in childhood CD22-positive B-cell ALL. Inotuzumab ozogamicin combination therapies are also being evaluated in the phase I/II or II setting in ALL and chronic myeloid leukaemia and in the phase I setting in Burkitt's lymphoma. This article summarises the milestones in the development of inotuzumab ozogamicin leading to this first approval for ALL.