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阿斯利康在美国撤销Imfinzi的晚期膀胱癌适应症

2021-02-22 Allan MedSci原创

阿斯利康近日宣布,在美国,阿斯利康自愿撤销免疫疗法Imfinzi治疗晚期膀胱癌的适应症。

阿斯利康近日宣布,在美国,阿斯利康自愿撤销免疫疗法Imfinzi治疗晚期膀胱癌的适应症。

2017年5月,在I / II期研究中显示出有希望的肿瘤缓解率和晚期实体瘤缓解数据之后,美国食品药品监督管理局(FDA)批准Imfinzi(durvalumab)治疗晚期膀胱癌。

Imfinzi在此适应症中的批准取决于III期DANUBE试验的阳性结果。但是,免疫疗法Imfinzi(durvalumab)在2020年仍未达到这项研究的主要终点。

对于肿瘤细胞和/或肿瘤浸润性免疫细胞高表达(≥25%)PD-L1的患者,与标准治疗相比,Imfinzi单一疗法未达到改善总生存(OS)的主要终点。此外,该公司表示,除了tremelimumab以外,Imfinzi也未达到其他主要终点,且无论患者PD-L1表达水平如何。

阿斯利康在一份声明中表示,此次撤回不会影响美国以外的适应症,也不会影响Imfinzi在美国的其他适应症。阿斯利康肿瘤业务部执行副总裁Dave Fredrickson表示:“免疫疗法在过去几年中发展迅速,为患者带来了前所未有的新选择。虽然此次撤药令人失望,但我们仍会致力于为患者带来新的治疗选择”。

 

原始出处:

http://www.pharmatimes.com/news/az_withdraws_imfinzi_indication_in_the_us_for_advanced_bladder_cancer_1363811

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    2021-02-24 swallow
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    2021-02-23 留走人康

    膀胱癌真怪,明明是免疫敏感性肿瘤,为什么PD-1治疗效果不好呢?难道靶点不对?将来CD47会不会有效

    0

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