Kite向FDA提交第二种CAR-T细胞疗法的申请,以治疗套细胞淋巴瘤

2019-12-16 不详 MedSci原创

吉利德(Gilead)收购的Kite已向美国食品和药物管理局(FDA)提交了第二种CAR-T疗法KTE-X19的申请,有望成为套细胞淋巴瘤(MCL)的首例细胞疗法。

吉利德(Gilead)收购的Kite已向美国食品和药物管理局(FDA)提交了第二种CAR-T疗法KTE-X19的申请,有望成为套细胞淋巴瘤(MCL)的首例细胞疗法。

KTE-X19的提交是基于II期ZUMA-2试验的数据,单次输注该细胞疗法后,总缓解率为93%,完全缓解率为67%。

在安全性分析中,分别在15%和31%的患者中发现3级或更高水平的细胞因子释放综合症(CRS)和神经系统事件,但未观察到5级CRS或神经系统事件。

Kite临床开发全球负责人Ken Takeshita说:"尽管有最新进展,但对于复发/难治性MCL患者仍然非常需要新的治疗方法,因此此次CAR-T疗法的申请对于MCL而言是一个特别重要的里程碑。"

该公司表示,预计明年年初将在欧洲提交用于治疗MCL的KTE-X19申请。

原始出处:


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    2020-07-08 仁者大医
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    2019-12-18 shuangle

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