Imbruvica和Gazyvo联用获FDA批准用于治疗慢性淋巴细胞白血病

2019-01-28 MedSci MedSci原创

重镑白血病药物Imbruvica再次扩大其应用范围,近日获得FDA批准与Gazyvo联合用于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL / SLL)的一线治疗。

重镑白血病药物Imbruvica再次扩大其应用范围,获得FDA批准与Gazyvo联合用于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL / SLL)的一线治疗。

此次FDA的批准是针对CLL / SLL患者的首次非化疗联合治疗方案,这次的批准也代表着Imbruvica自2013年11月美国推出以来第10次被批准新适应症。

临床研究显示,在中位随访31个月后,Imbruvica加obinutuzumab联用,与苯丁酸氮芥和obinutuzumab联用相比,无进展生存期显着改善,进展或死亡风险降低了77%。

该组合治疗的高风险患者(17p缺失/ TP53突变,11q缺失,或IGHV未突变),进展或死亡风险降低了85%。

这些结果都提示Imbruvica可能其他类型患者中也有很好的疗效,包括非老年人群和化学免疫疗法候选患者。

原始出处:


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    2019-04-01 仁心济世
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    2019-01-30 syscxl

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