Laurenti Luca, Innocenti Idanna, Autore Francesco, Sica Simona, Efremov Dimitar G
Department of Hematology, Catholic University of the Sacred Heart, Rome, Italy.
Molecular Hematology, International Centre for Genetic Engineering and Biotechnology, Monterotondo, Italy.
Onco Targets Ther. 2016 Jan 20;9:421-9. doi: 10.2147/OTT.S72845. eCollection 2016.
Ofatumumab is one of the three anti-CD20 monoclonal antibodies currently available for the treatment of chronic lymphocytic leukemia (CLL). The US Food and Drug Administration (FDA) approved the use of ofatumumab in patients with CLL refractory to fludarabine and alemtuzumab in 2009, and the European Medicines Agency (EMA) granted approval for the same indication in 2010. Subsequent positive results of ofatumumab in combination with chlorambucil in treatment-naïve patients led the FDA in April 2014 to approve the use of this combination for first-line treatment of patients with CLL for whom fludarabine-based therapy is considered inappropriate. Later that year, the EMA approved the use of ofatumumab in combination with chlorambucil or bendamustine for the same indication. Ofatumumab has also shown potential as maintenance therapy for patients with relapsed CLL; an application to broaden the label for ofatumumab as maintenance therapy was submitted earlier this year to the EMA and FDA. Finally, ofatumumab has shown promising activity in combination with ibrutinib or idelalisib in relapsed/refractory CLL patients; combinations of ofatumumab with B-cell-receptor pathway inhibitors could represent another potential use of this antibody in the near future.
奥法木单抗是目前可用于治疗慢性淋巴细胞白血病（CLL）的三种抗CD20单克隆抗体之一。2009年，美国食品药品监督管理局（FDA）批准奥法木单抗用于治疗对氟达拉滨和阿仑单抗耐药的CLL患者，欧洲药品管理局（EMA）于2010年批准了相同适应症。随后，奥法木单抗联合苯丁酸氮芥用于初治患者的阳性结果促使FDA在2014年4月批准该联合用药用于一线治疗不适合接受基于氟达拉滨治疗的CLL患者。同年晚些时候，EMA批准奥法木单抗联合苯丁酸氮芥或苯达莫司汀用于相同适应症。奥法木单抗还显示出作为复发CLL患者维持治疗的潜力；今年早些时候已向EMA和FDA提交了扩大奥法木单抗作为维持治疗适应症的申请。最后，奥法木单抗与伊布替尼或idelalisib联合用于复发/难治性CLL患者显示出有前景的活性；奥法木单抗与B细胞受体途径抑制剂的联合使用可能在不久的将来代表该抗体的另一种潜在用途。
