阿斯利康的PD-L1单抗Imfinzi治疗小细胞肺癌,获得FDA的孤儿药物指定

2019-07-12 不详 MedSci原创

阿斯利康宣布其PD-L1单抗Imfinzi(durvalumab)治疗小细胞肺癌(SCLC),获得美国食品和药物管理局(FDA)的孤儿药物指定(ODD)。

阿斯利康宣布其PD-L1单抗Imfinzi(durvalumab)治疗小细胞肺癌(SCLC),获得美国食品和药物管理局(FDA)的孤儿药物指定(ODD)。

III期CASPIAN试验显示,与单独化疗相比,使用Imfinzi联合依托泊苷和铂类治疗广泛分期SCLC患者的总体生存率具有统计学显着性和临床意义的改善,达到了其主要终点。

该药物是一种非人单克隆抗体,可与PD-L1结合并阻断PD-L1与PD-1和CD80的相互作用,从而对抗肿瘤的免疫逃避策略并释放免疫反应的抑制作用。

研发肿瘤学执行副总裁JoséBaselga表示,CASPIAN试验是第一个提供"将免疫疗法与不同铂类治疗小细胞肺癌相结合的灵活性"的试验,该公司"渴望为SCLC患者扩大治疗方案,并期待与监管机构合作,尽快提供新的治疗选择。"

根据第三阶段PACIFIC试验,目前在包括美国,欧盟和日本在内的超过45个国家被批准,用于化疗和放疗后不可切除的III期非小细胞肺癌NSCLC)。

肺癌是男性和女性癌症死亡的主要原因,约占所有癌症死亡人数的五分之一。肺癌广泛分为NSCLC和SCLC,约15%被分类为SCLC。大约三分之二的SCLC患者被诊断为患有广泛期疾病,这类患者的癌症已经穿过肺广泛地向身体其他部分扩散。

原始出处:


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    2019-07-14 smartjoy
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    2019-07-14 swallow
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    2019-07-13 lovetcm

    PD-L1在小细胞肺癌中表现明显优于PD-1,但原因呢?

    0

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    2019-07-13 SAS

    0

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