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FDA批准阿斯利康的PD-L1单抗Imfinzi,用于广泛期小细胞肺癌的一线治疗

2020-04-01 MedSci原创 MedSci原创

阿斯利康表示,Imfinzi被FDA批准用于与护理标准(SoC)化学疗法--依托泊苷以及卡铂或顺铂(铂-依托泊苷)组合使用。

阿斯利康(AstraZeneca)宣布其PD-L1单抗Imfinzi(durvalumab)已获得美国食品和药物管理局(FDA)批准,用于一线治疗广泛期小细胞肺癌(ES-SCLC)的成人患者。

阿斯利康表示,Imfinzi被FDA批准用于与护理标准(SoC)化学疗法--依托泊苷以及卡铂或顺铂(铂-依托泊苷)组合使用。

这项批准是基于CASPIAN III期试验的积极结果,在该试验中,死亡风险降低了27%,中位总生存期(OS)为13.0个月,而SoC单独使用为10.3个月。

该公司肿瘤事业部执行副总裁Dave Fredrickson表示"Imfinzi是目前唯一一种与化学疗法联合使用后,在广泛期小细胞肺癌患者中显示出明显的生存获益的免疫疗法。该发现是治疗这种破坏性疾病的重要进步。"

结果还显示,Imfinzi联合SoC的客观响应率提高到了68%,而SoC单独使用为58%。

肺癌是男女癌症死亡的主要原因,约占美国所有癌症死亡的四分之一。

原始出处:

http://www.pharmatimes.com/news/fda_approves_imfinzi_for_extensive-stage_sclc_1332715

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    2021-02-02 bugit
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    2020-04-03 smartjoy
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    2020-04-03 swallow
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