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美国食品和药物管理局批准摘要:Idecabtagene Vicleucel用于治疗三级暴露,复发或耐火性多发性髓瘤
Poornima Sharma1, Xue Lin1, Zhenzhen Xu1
1Center for Biologics Evaluation and Research, Silver Spring, Maryland.
概括
美国食品和药物管理局批准了idecabtagene vicleucel (ide-cel) 治疗复发性/耐药性多发性骨髓瘤,显示无进展的生存时间明显更长. 尽管存在早期生存方面的担忧,但利益风险概况被认为是有利的.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 多发性骨髓瘤是一种血液性恶性瘤,对于复发/耐药病例的治疗选择有限.
- 之前的治疗包括免疫调节剂,蛋白酶体抑制剂和抗CD38抗体.
- 化学抗原受体T细胞 (CAR-T) 疗法代表了血液恶性瘤的新方法.
研究的目的:
- 评估idecabtagene vicleucel (ide-cel) 在患有复发性或耐火性多发性髓瘤的成年人中的疗效和安全性.
- 为了将ide-cel与标准护理治疗进行比较,在大量预先治疗的患者群体中.
- 评估无进展生存期 (PFS) 作为主要终点.
主要方法:
- KarMMa-3试验:一个随机的,开放的标签研究,涉及386名患者.
- 单次输注ide-cel与研究人员选择标准护理方案的比较.
- 主要终点:无进展生存率 (PFS).
主要成果:
- 与标准护理相比,Ide-cel的PFS显著更长 (HR=0.49;P<0.0001).
- 理想细胞治疗中PFS的中位数为13.3个月,标准治疗中为4.4个月.
- 与ide-cel一起观察到高比例的细胞因子释放综合征 (91%) 和神经毒性 (46%),其中9%是致命的不良反应.
结论:
- Idecabtagene vicleucel是FDA批准的第一个CAR-T疗法,用于在先前的治疗线之后复发/耐药的多发性骨髓瘤.
- 该研究满足了其主要终点,显示了PFS的显著改善.
- 尽管早期的整体存活率存在担忧,但瘤药物咨询委员会赞成在这个适用症中使用ide-cel的益处风险概况.
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