葛兰素史克与Genmab公司宣称，FDA批准奥法木单抗（Ofatumumab；商品名Arzerra）作为一线治疗药物，与苯丁酸氮芥合并用药治疗不适合使用氟达拉滨治疗的慢性淋巴细胞白血病(CLL)患者。

Genmab的CEO Jan van de Winkel指出，奥法木单抗是唯一一款获批与苯丁酸氮芥合并用于一线CLL治疗的CD20抗体。

根据两家公司的信息，FDA的决定是基于3期COMPLEMENT I临床研究数据，该试验的受试者为447名既往无治疗史的CLL患者。患者被随机配给奥法木单抗+苯丁酸氮芥，或单独使用苯丁酸氮芥。

结果证实，奥法木单抗治疗组患者平均无进展生存期(PFS)有明显改善，获得22.4个月的PFS，相比之下，仅使用苯丁酸氮芥的患者其平均PFS为13.1个月。

葛兰素史克与Genmab公司指出，除了嗜中性白血球减少症和白血球减少症，奥法木单抗治疗组的3级或更高级的非输液相关反应总发生率与苯丁酸氮芥单独用药组类似。同时，输液反应(IRs)在合并用药组67%的患者中出现。

奥法木单抗的新适应症申请是FDA在优先审评程序下进行审评的。两家公司去年10月在欧盟提交了奥法木单抗与一种烷化剂为基础的治疗药物合并用于一线治疗相同患者人群的申请。

FDA expands use of GlaxoSmithKline, Genmab's Arzerra to include first-line treatment of CLL

GlaxoSmithKline and Genmab announced that the FDA expanded approval for Arzerra (ofatumumab), in combination with chlorambucil, as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are unsuitable for fludarabine-based therapy. Genmab CEO Jan van de Winkel noted that Arzerra "is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab."

According to the companies, the FDA decision was based on data from the PHASE III COMPLEMENT I study involving 447 treatment-naïve patients with CLL for whom fludarabine-based therapy was deemed inappropriate. Patients were randomised to receive either Arzerra plus chlorambucil, or chlorambucil alone. Results demonstrated that median progression-free survival (PFS) was significantly improved among patients in the Arzerra group, who achieved PFS of 22.4 months, versus 13.1 months for those only administered chlorambucil.

GlaxoSmithKline and Genmab noted that with the exception of neutropaenia and leukopaenia, the overall rate of non-infusion-related reactions that were Grade 3 or higher in the Arzerra group was similar to chlorambucil alone. Meanwhile, infusion reactions (IRs) were observed in 67 percent of patients in the combination treatment arm, and the companies noted that 10 percent of IRs were Grade 3 or greater.

The application for expanded approval of Arzerra was eva1uated by the US regulator under a priority review designation. The companies filed an EU application last October to market Arzerra in combination with an alkylator-based therapy for first-line use in the same patient population.

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