替伊莫单抗/人血白蛋白,泽娃灵KIT FOR PREP INDIUM-111

药店国别:

产地国家:美国

处方药:

所属类别: 1套

包装规格: 1套

计价单位:

生产厂家中文参考译名

生产厂家英文名:SPECTRUM PHARMS

原产地英文商品名:Zeva lIN IN-111 1kit

原产地英文药品名:KIT FOR PREP INDIUM-111/IBRITUMOMAB TIUXETAN/ALBUMIN HUMAN

中文参考商品译名:泽娃灵IN-111 1套

中文参考药品译名:KIT FOR PREP INDIUM-111/替伊莫单抗/人血白蛋白

曾用名:

简介:

Zeva lin(泽娃灵)Zeva lin是世界上第一个放射性标记的单克隆抗体,2002年在美国上市,被批准用于难治复发B细胞非霍奇金淋巴瘤的治疗。以Zeva lin为代表的放射免疫标志着人类对于非霍奇金淋巴瘤的治疗进入了一个新的时代,Zeva lin结合了单克隆抗体出色的靶向性和放射性同位素强大的放射治疗作用,因此可以最大程度地杀灭肿瘤细胞。Zeva lin由放射性同位素钇90和CD20单抗组成,与其他放射性同位素相比,钇90放射纯β射线,具有更强的射线能量。

同时,由于钇90不产生γ射线,对医护人员及患者家属非常安全,因此FDA批准Zeva lin可用于门诊病人,并无需隔离防护。与当今流行的单克隆抗体治疗(如利妥昔单抗)相比,Zeva lin显示出明显的优势。随机III期临床对照研究表明,Zeva lin与利妥昔单抗(CD20单抗)相比,总完全缓解率显著提高(80%:56%),对于达到完全缓解的病人,至疾病进展时间延长了近一倍。

随着研究的深入,Zeva lin将造福越来越多的淋巴瘤患者。在北京参加会议的先灵公司专家斯托克日前向记者介绍说,新药同时利用了单克隆抗体和放射线两种手段,比单独使用抗体治疗效果更好。B细胞淋巴瘤是淋巴细胞性白血病的一种,患者的一类免疫细胞——B细胞发生癌变,出现恶性增生,肿瘤细胞通常成团分布。单克隆抗体是成分单一的抗体蛋白质,每种单克隆抗体能够识别肿瘤细胞表面一种特定的蛋白质,与这种“靶子”结合,触发一系列反应,导致肿瘤细胞死亡。

这种名为Zeva lIN的新药是一种放射免疫制剂,使用了专门攻击B细胞表面的CD20蛋白质分子的单克隆抗体,同时携带有放射性元素钇-90。由于淋巴瘤细胞对放射线较为敏感,钇-90所释放的射线可以与单克隆抗体联合,形成“交叉火力”,深入肿瘤内部杀死细胞,比仅仅使用单克隆抗体杀死肿瘤更加有效。单独使用的抗体,药力难以到达肿瘤深部。新药中的单克隆抗体只能与肿瘤细胞结合,因此能准确地把放射源带到肿瘤细胞团中。由于90%的放射能量释放在放射源周围5毫米范围内,放射线对正常组织的损害比较小。

一项临床研究表明,仅使用抗体治疗时没有疗效或疗效轻微的患者,有75%的人使用Zeva lIN后病情有明显好转,免疫系统开始恢复,血液成分逐渐转向正常。另一项143名患者参加的对照试验中,使用Zeva lIN治疗的一组,有80%的患者病情好转;而仅使用抗体、不使用放射线的一组患者,仅56%对治疗有反应。不过,目前临床试验还不能证明Zeva lIN对高恶度B细胞淋巴瘤即侵袭性淋巴瘤也有显著疗效。先灵公司的莫斯迈尔博士说,由于单克隆抗体比较难制取,这种新药的成本昂贵。他希望将来能找到费用低廉的高效生产技术,例如用转基因庄稼和羊奶来获取抗体。

毒副作用信息2005年11月9日,美国FDA网站CDER网页10月28日发布消息:Biogen Idec公司与FDA共同向卫生保健专业人员通报了泽娃灵(Zeva lin)处方信息中的黑框警告、警告和不良反应三项做出修改一事,修改内容中描述了采用泽娃灵治疗方案可能与出现严重的皮肤或皮肤粘膜反应有关,有些反应甚至会产生致命的后果。这些信息来自上市后的使用报告。已产生严重皮肤或皮肤粘膜反应的病人不应该继续使用Zeva lin治疗方案,同时应该寻求即时的药品评价。

英文版说明书

Zeva lin (ibritumomab tiuxetan)Company: Biogen IDECApproval Status: Approved February 2002Treatment for: Non-Hodgkin’s lymphomaAreas: OncologyGeneral InformationIn February 2002, Zeva lin was the first radioimmunotherapy to receive FDA approval. Zeva lin is indicated for the treatment of relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (NHL). This indication includes patients with Rituxan (rituximab)-refractory follicular NHL. Zeva lin has been approved as part of a therapeutic regimen involving Rituxan.Zeva lin consists of a monoclonal antibody linked to the radioactive isotope yttrium-90. After infusion into a patient, the monoclonal antibody targets the CD20 antigen, which is found on the surface of mature B cells and B-cell tumors. In this manner, cytotoxic radiation is delivered directly to malignant cells.Clinical ResultsZeva lin received both a full approval and an accelerated approval based on results from two major US efficacy studies.The study that supported the full approval of Zeva lin included 54 subjects. The subjects were diagnosed with relapsed follicular lymphoma, and they no longer adequately responded to Rituxan treatment. An overall response rate of 74% was achieved with Zeva lin treatment, with 15% of subjects experiencing a complete response.Accelerated approval of Zeva lin was supported by a randomized, controlled phase III trial.The trial included 143 subjects with relapsed or refractory, low grade or follicular NHL or transformed B-cell NHL. An overall response rate of 80% was obtained in subjects receiving the Zeva lin therapeutic regimen (73 subjects), compared to 56% for the subjects receiving Rituxan alone (70 subjects).Thirty percent of Zeva lin-treated subjects experienced a complete response, compared to a 16% complete response rate for Rituxan-treated subjects.Side EffectsIn clinical trials, serious adverse reactions caused by the Zeva lin therapeutic regimen included infections, allergic reactions, and hemorrhage while thrombocytopenic. In addition, the development of myeloid malignancies and dysplasias have been reported.Adverse events that occurred in greater than 5% of subjects include(but are not limited to) the following:NauseaVomitingDiarrheaAnorexiaThrombocytopenia (decreased number of blood platelets)Neutropenia (decreased number of white blood cells)AnemiaArthralgia (joint pain)DizzinessDyspnea (difficult or labored breathing)Increased coughMechanism of ActionThe complementarity-determining regions of Ibritumomab bind to the CD20 antigen on B lymphocytes.Ibritumomab, like Rituximab, induces apoptosis in CD20+ B-cell lines in vitro.The chelate tiuxetan, which tightly binds In-111 or Y-90, is covalently linked to the amino groups of exposed lysines and arginines contained within the antibody. The beta emission from Y-90 induces cellular damage by the formation of free radicals in the target and neighboring cells.(from Zeva lin Prescribing Information)Additional InformationSchering AG has the marketing rights to Zeva lin outside of the United States.For more information on Zeva lin, please visit IDEC Pharmaceuticals.Additional information on non-Hodgkin’s lymphoma can be obtained through the National Cancer Institute.

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