英国NICE积极推荐将赛诺菲的CD38单抗Sarclisa,用于治疗复发/难治性多发性骨髓瘤

2020-10-16 MedSci原创 MedSci原创

CD38单抗Sarclisa联合地塞米松,将复发/难治性多发性骨髓瘤患者无进展生存期延长了11.5个月。

英国国家卫生与临床优化研究所(NICE)建议将赛诺菲(Sanofi)的 CD38单抗Sarclisa(isatuximab)与泊马度胺(pomalidomide)和地塞米松(dexamethasone,pom-dex)联合,用于已接受过三项先前疗法并且至少两种先前疗法包括来那度胺和蛋白酶体抑制剂的复发/难治性多发性骨髓瘤成年患者。

<a href='https://www.medsci.cn/search?q=FDA'>FDA</a> Approves Sanofi's Sarclisa for Multiple Myeloma – PharmaLive

多发性骨髓瘤(图片来源:pharmaLive)

该建议基于ICARIA-MM试验数据,该试验证明Sarclisa加pom-dex可使成年患者的疾病进展或死亡风险降低40%。与仅使用pom-dex进行治疗时的6.5个月相比,联合治疗将无进展生存期延长至11.5个月。总体而言,Sarclisa将无进展生存期延长了5.0个月。

还发现在pom-dex中添加Sarclisa具有良好的耐受性,与pom-dex组相比,治疗中断或致命事件的发生率没有增加。

CD38单抗作用原理(图片来源:CD38: A Target for Immunotherapeutic Approaches in Multiple Myeloma. Front Immunol. 2018

在英国,每年约有5700人被诊断患有多发性骨髓瘤,每年约有3000多例与多发性骨髓瘤相关的死亡。患者通常经历频繁的复发,并且患者逐渐对多种疗法产生抗性。

原始出处:

http://www.pharmatimes.com/news/sanofis_sarclisa_bags_nice_recommendation_1353389

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    2020-12-23 jml2009
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    2020-10-18 fusion
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    2020-10-18 freve

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