CHMP建议批准Sarclisa(isatuximab)与卡非佐米和地塞米松联合治疗复发性多发性骨髓瘤

2021-02-27 Allan MedSci原创

与单独使用Kd相比,Sarclisa联合Kd将患者的疾病进展或死亡风险降低了47%。

近日,欧洲药品管理局(EMA)人用药品委员会(CHMP)建议批准Sarclisa(isatuximab)与卡非佐米和地塞米松(Kd)联合用于复发性多发性骨髓瘤( MM),这些患者先前至少接受过一种疗法。

赛诺菲肿瘤与儿科创新全球发展主管Peter Adamson说:“Sarclisa与两种标准护理方案相结合已显示出优异的结果。我们期待与欧盟委员会合作,将Sarclisa提供给更多患者”。

Sarclisa目前已在欧洲获准与pomalidomide和dexamethasone联合使用,用于治疗至少接受过两种先前疗法(包括来那度胺和蛋白酶体抑制剂)的复发难治MM患者。目前,欧盟尚未批准将Sarclisa与卡非佐米和地塞米松联合使用,但是预计在未来几个月内,欧盟委员会将决定是否扩大适应症。

CHMP的正面意见基于IKEMA III期研究的数据,该研究是一项随机、多中心、开放标签的临床试验,纳入了16个国家的302例MM患者。IKEMA的主要终点是无进展生存期(PFS)。结果显示,与单独使用Kd相比,Sarclisa联合Kd将患者的疾病进展或死亡风险降低了47%(危险比0.531、99%CI 0.318-0.889,p = 0.0007)。

 

原始出处:

https://www.firstwordpharma.com/node/1804523?tsid=4

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    2021-04-21 snf701207
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    2021-10-11 jml2009
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    2021-03-01 科研科研科研

    联合地塞米松治疗复发性多发性骨髓瘤

    0

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    2021-03-01 医生2394
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