FDA授予阿斯利康的PD-L1单抗Imfinzi优先审查

2019-12-02 不详 MedSci原创

阿斯利康(AstraZeneca)宣布,美国食品药品监督管理局(FDA)已接受其补充生物制剂许可申请(sBLA),并为其靶向程序性的死亡-配体1(PD-L1)单克隆抗体Imfinzi(durvalumab)授予了优先评审资格。

阿斯利康(AstraZeneca)宣布,美国食品药品监督管理局(FDA)已接受其补充生物制剂许可申请(sBLA),并为其靶向程序性的死亡-配体1(PD-L1)单克隆抗体Imfinzi(durvalumab)授予了优先评审资格。

该决定是基于在先前未接受治疗的广泛期小细胞肺癌(SCLC)患者中阳性III期CASPIAN试验的结果,该试验发现Imfinzi与当前的护理标准相结合(依托泊苷与顺铂或卡铂联合使用)在总体生存率方面具有统计学意义和临床意义的改善。

更具体地说,Imfinzi联合化疗的中位总生存期为13.0个月,而仅标准护理为10.3个月。此外,结果显示,估计33.9%的患者在用Imfinzi联合化疗治疗后18个月存活,而接受SoC的患者为24.7%。该试验正在23个国家(包括美国,欧洲,南美,亚洲和中东)的200多个中心进行。

肺癌是癌症死亡的主要原因,约占所有癌症死亡的五分之一。该疾病大致分为非小细胞肺癌和小细胞肺癌,约15%被归类为小细胞肺癌。

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    2021-04-02 我要当大牛

    阿斯利康全球总部位于英国伦敦

    0

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    2019-12-04 smartjoy
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    2019-12-04 swallow
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