ST LOUIS (MD Consult) - On September 4, 2009, Spectrum Pharmaceuticals announced that it has received approval from the US Food and Drug Administration (FDA) for an expanded label for Zevalin (ibritumomab tiuxetan). This approval allows for the use of Zevalin in the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma (NHL) who achieve a partial or complete response to first-line chemotherapy. Zevalin had been previously approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
Zevalin is a CD20-directed radiotherapeutic antibody that is administered as part of the Zevalin therapeutic regimen. This regimen consists of 3 components: rituximab, Indium-111 radiolabeled Zevalin for imaging, and Yttrium-90 radiolabeled Zevalin for therapy. The Zevalin therapeutic regimen is a form of cancer therapy called radioimmunotherapy (RIT). Radioimmunotherapy is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
The FDA's approval for this new indication of Zevalin for non-Hodgkin's lymphoma was granted on the basis of data from the First-line Indolent Therapy (FIT) study. Investigators for this multicenter, randomized, open-label, phase 3 study evaluated the safety and efficacy of Zevalin in 414 patients with CD20-positive follicular NHL who had achieved a partial response or a complete response after receiving a first-line chemotherapy regimen. Patients were treated with one of the following first-line chemotherapy regimens: chlorambucil, fludarabine, fludarabine-containing regimen, CVP/COP (cyclophosphamide, vincristine [Oncovin], prednisone), CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CHOP-like, or rituximab-containing chemotherapy. At 3.5 years of follow-up, results of the FIT trial demonstrated that when used as part of first-line chemotherapy for patients with follicular NHL, Zevalin significantly improved the median progression-free survival time from 18 months (control arm) to 38 months (Zevalin arm) (P < .0001).
Updated results with an additional year of follow-up from the FIT study were presented at the 2008 annual meeting of the American Society of Hematology. According to the manufacturer, the safety profile of Zevalin was consistent with previous clinical studies, with hematologic toxicity as the most common adverse reaction in the FIT study.
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圣路易斯（MD Consult）——光谱制药公司（Spectrum Pharmaceuticals）在2009年9月4日宣布已收到美国食品药品管理局（FDA）的批件，允许扩大Zevalin（商品名：泽娃灵；通用名：替伊莫单抗）的适应证范围。Zevalin获准用于经一线化疗后部分缓解或完全缓解的滤泡型非霍奇金淋巴瘤（NHL）初治患者。在此之前，Zevalin已经获准用于治疗复发性或难治性、低度恶性或滤泡B细胞性NHL患者。
Zevalin作为一种CD20靶向性放射治疗抗体，是Zevalin治疗方案的一部分。该方案包括3个组成部分：利妥昔单抗、显像用铟-111标记的Zevalin以及治疗用钇-90标记的Zevalin。Zevalin治疗方案是一种称为放射免疫治疗（RIT）的肿瘤治疗形式。放射免疫治疗作为革新性的肿瘤疗法，其作用机制并不同于传统的化疗。RIT疗效的发挥依赖于靶向性单克隆抗体的生物学效应经β放射性核素治疗效应放大后产生的综合性效应。
美国FDA批准Zevalin治疗NHL的新适应证得到了“一线无痛治疗”（FIT）研究的数据支持。在该多中心随机开放性III期临床试验中，研究人员评估了Zevalin在414例经一线化疗方案治疗后达到部分缓解或完全缓解的CD20阳性滤泡性NHL患者的安全性和有效性。患者接受了下列一线化疗方案的其中一种：丁酸氮芥（chlorambucil）、氟达拉滨（fludarabine）、含氟达拉滨方案、CVP/COP方案（环磷酰胺、长春新碱、强的松）、CHOP方案（环磷酰胺、阿霉素、长春新碱、泼尼松）、CHOP类似方案或含利妥昔单抗的化疗方案。在为期3.5年的随访中，FIT试验的结果表明：在滤泡性NHL患者的一线化疗方案中加入Zevalin，可将患者的中位无进展生存时间由对照组的18个月提高到Zevalin组的38个月（P<0 .0001）。
在2008年美国血液学会年会上，研究人员报告了FIT研究在随访4.5年后的最新结果。生产商指出，Zevalin的安全性数据与以往的临床研究数据一致，血液毒性是研究中最常见的不良反应。
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