III期ADAURA试验:Tagrisso在EGFR突变型肺癌患者的辅助治疗中具有压倒性疗效

2020-04-11 Allan MedSci原创

III期ADAURA临床试验显示,Tagrisso(osimertinib)在辅助治疗IB、II和IIIA期表皮生长因子受体突变(EGFRm)非小细胞肺癌(NSCLC)且肿瘤完整切除的患者具有显著疗效

III期ADAURA临床试验显示,Tagrisso(osimertinib)在辅助治疗IB、II和IIIA期表皮生长因子受体突变(EGFRm)非小细胞肺癌(NSCLC)且肿瘤完整切除的患者具有压倒性疗效。因此,独立数据监察委员会(IDMC)建议提前终止III期ADAURA试验。

阿斯利康肿瘤学研究与开发执行副总裁José Baselga表示:“我们对提前结束ADAURA III期临床试验感到很高兴。非小细胞肺癌是一种灾难性的肿瘤,EGFR靶向药物现在首次可以提供治愈的希望”。

根据在显微镜下的外观,肺癌可以分为两大类:小细胞肺癌(small cell lung cancer)和非小细胞肺癌(non small cell lung cancer)。非小细胞肺癌更为常见,目前约占肺癌病例的87%。非小细胞型肺癌包括鳞状细胞癌(鳞癌)、腺癌、大细胞癌,与小细胞癌相比其癌细胞生长分裂较慢,扩散转移相对较晚。

 

原始出处:

https://www.firstwordpharma.com/node/1714836

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    2020-04-13 般若傻瓜
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    2020-04-13 liuyiping
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    2020-04-11 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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中国监管机构批准阿斯利康的Tagrisso作为EGFR突变型NSCLC的一线治疗药物

阿斯利康近日表示,中国国家医疗产品管理局(NMPA)已经批准其Tagrisso(osimertinib),用于一线治疗局部晚期或转移性非小细胞肺癌(NSCLC)的成人患者,这些患者的肿瘤细胞具有EGFR外显子19缺失或外显子21(L858R)的基因突变。

阿斯利康的EGFR抑制剂Tagrisso在III期临床试验中显著改善NSCLC的总体存活率

阿斯利康公布III期FLAURA试验中Tagrisso(osimertinib)在既往未治疗的、具有表皮生长因子受体(EGFR)突变的局部晚期或转移性非小细胞肺癌(NSCLC)患者中延长了总生存率(OS)的阳性结果,达到了该III期实验的次要终点。

AZ的肺癌药物Tagrisso在欧洲获准作为一线用药

欧洲的监管顾问支持阿斯利康公司的肺癌药物Tagrisso作为一线用药的批准。欧洲药品管理局人用药品委员会(CHMP)建议扩大该药品的标签,以包括表皮生长因子受体(EGFR)突变的成人局部晚期或转移性非小细胞肺癌(NSCLC)的成人一线治疗。该研究的首席医疗官Sean Bohen指出:"该积极的建议承认Tagrisso的osimertinib具有欧洲EGFR突变NSCLC患者的一线治疗新标准的潜力。