Reda G, Orofino N, Cassin R, Sciumè M, Fattizzo B, Cortelezzi A
a Oncohematology Department , Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico and University of Milan , Milano , Italy.
Expert Opin Drug Saf. 2016 Jun;15(6):865-73. doi: 10.1517/14740338.2016.1165665. Epub 2016 Apr 7.
Obinutuzumab is a novel glycoengineered type II anti-CD20 monoclonal antibody (MoAb) with a higher affinity for CD20 epitope. It was approved by the United States Food and Drug Administration (FDA) in November 2013 for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia (CLL).
This article evaluates the safety of obinutuzumab in CLL patients, also addressing pharmacokinetics/pharmacodynamics (PK/PD), clinical use and efficacy. Moreover, a comparison with other anti-CD20 MoAb is performed. The principal available studies on obinutuzumab are reviewed, focusing on CLL. A PubMed literature search (August 2002 to September 2015) was conducted using the terms obinutuzumab, GA101, anti-CD20 antibody, and CLL.
Obinutuzumab, a third-generation anti-CD20 MoAb, is a safe and effective treatment for elderly patients who are un-fit for fludarabine-based regimen. Its use, proven in the CLL11 study and the results of many ongoing trials evaluating other obinutuzumab-based regimen can lead obinutuzumab to be a candidate to replace rituximab as the first-line treatment option.
奥滨尤妥珠单抗是一种新型的糖基工程化II型抗CD20单克隆抗体（MoAb），对CD20表位具有更高的亲和力。2013年11月，它被美国食品药品监督管理局（FDA）批准与苯丁酸氮芥联合用于既往未经治疗的慢性淋巴细胞白血病（CLL）。
本文评估了奥滨尤妥珠单抗在CLL患者中的安全性，还探讨了其药代动力学/药效学（PK/PD）、临床应用及疗效。此外，还与其他抗CD20 MoAb进行了比较。回顾了关于奥滨尤妥珠单抗的主要现有研究，重点是CLL。使用奥滨尤妥珠单抗、GA101、抗CD20抗体和CLL等术语在PubMed上进行了文献检索（2002年8月至2015年9月）。
奥滨尤妥珠单抗作为第三代抗CD20 MoAb，对于不适合基于氟达拉滨方案的老年患者是一种安全有效的治疗方法。其在CLL11研究中的应用以及许多正在进行的评估其他基于奥滨尤妥珠单抗方案的试验结果，可能使奥滨尤妥珠单抗成为替代利妥昔单抗作为一线治疗选择的候选药物。
