单克隆抗体Arzerra获准用于难治性慢性淋巴细胞白血病

Monoclonal antibody Arzerra approved for refractory chronic lymphocytic leukemia ST LOUIS (MD Consult) - On October 26, 2009, the US Food andDrugAdministration (FDA) granted accelerated approval to Arzerra(ofatumumab) for the treatment of patients with chronic lymphocytic leukemia (CLL)whosediseasehasbeenrefractory to treatment with fludarabineandalemtuzumab.

Arzerra is a monoclonal antibody that provokes an immune responseagainstnormal and malignant B cells. Arzerra attaches to small- and large-loop epitopes on the protein molecule known as CD20. This molecule is found on the surface of B cells, the type of cell that becomes cancerous in CLL.

The FDA\'s accelerated approval process specifies that further study of the drug be undertaken.Themanufacturer is currently conducting a clinical trial in patients with CLL to confirm that the addition of Arzerra to standardchemotherapydelaysdisease progression.

Arzerra\'s effectiveness was assessed in 59 patients with CLL whose disease was refractory to other available therapies. The product\'s safety was evaluated in 2 studies that included 181 patients with cancer.
Commonly reported adverse effects included pneumonia, pyrexia, cough, diarrhea, fatigue, shortness ofbreath,rash,nausea,bronchitis,upperrespiratorytractinfections, and decreases in normal white blood cell and red blood cell counts.

The most serious adverse effect of Arzerra is an increased chance of infection. Patients at high risk for infection with hepatitis B should undergo screening before and during treatment with Arzerra. Patients with evidence of inactive infectious hepatitis should be monitored for reactivation of the infection during and after treatment. A risk also exists for the often-fatal disorder progressive multifocal leukoencephalopathy.

     圣路易斯(MD Consult)——2009年10月26日，美国食品药品管理局（FDA）通过加速审批程序批准Arzerra (ofatumumab) 用于氟达拉滨（fludarabine）和阿伦单（alemtuzumab）治疗无效的慢性淋巴细胞白血病(CLL)患者。

     Arzerra是一种可以引起免疫应答以对抗正常和恶性B细胞的单克隆抗体。其附着于名为CD20蛋白分子上的大小环状表位。CD20存在于B细胞表面，而这样的细胞在CLL中呈现为恶性。

     FDA的加速审批程序指出，该药需要进行进一步的研究。该药品生产厂商最近进行了一个CLL患者的临床试验，证实了标准化疗联合Arzerra延迟了疾病发展的进程。

     Arzerra的有效性在其他疗法治疗无效的59名CLL患者身上得到了评估。而该药的安全性在两项共包括181位癌症患者的研究中进行了评估。该药报道的常见副作用包括：肺炎、发热、咳嗽、腹泻、疲乏、气短、皮疹、恶心、支气管炎、上呼吸道感染以及正常白细胞和红细胞计数降低。
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     Arzerra最严重的副作用是增加了感染的机会。在Arzerra治疗前和治疗过程中需要筛查乙型肝炎感染的高危患者。在治疗前后，需要监控确诊为非活动期传染性肝炎患者体内病毒感染再激活情况。此外尚有发生致命性疾病——进行性多灶性脑白质病的危险。