FDA批准Karyopharm的Xpovio(selinexor)用于治疗多发性骨髓瘤

2020-12-20 Allan MedSci原创

FDA已批准Xpovio(selinexor)联合硼替佐米和地塞米松用于治疗多发性骨髓瘤成年患者,这些患者至少接受过一种疗法。

多发性骨髓瘤是一种浆细胞不正常增生,致使侵犯骨髓的恶性肿瘤。多发性骨髓瘤一开始多半没有症状,若病情加重时,会有骨痛、常被感染、贫血的症状。

Karyopharm Therapeutics近日表示,FDA已批准Xpovio(selinexor)联合硼替佐米和地塞米松用于治疗多发性骨髓瘤成年患者,这些患者至少接受过一种疗法。

该项批准是基于BOSTON III期试验的最新数据,该试验对402例复发或难治多发性骨髓瘤患者进行了1-3疗程的治疗。参与者被随机分为每周一次的Xpovio联合每周一次的硼替佐米联合低剂量地塞米松。

BOSTON III期试验的主要终点评估了无进展生存期(PFS),次要终点评估了总体缓解率(ORR)、周围神经病变率等。结果显示,在接受Xpovio联合治疗的患者中,中位PFS为13.9个月,而对照组为9.5个月。与单独使用硼替佐米联合地塞米松的ORR(62.3%)相比,Xpovio联合治疗组的ORR显著更高(76.4%)。

 

原始出处:

https://www.firstwordpharma.com/node/1784840?tsid=4

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    2021-12-04 jj000001
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