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贝达药业(300558.SZ):埃克替尼用于术后辅助治疗上市许可申请获受理
格隆汇 09-22 17:15

格隆汇9月22日丨贝达药业(300558.SZ)宣布,近日,公司收到国家药品监督管理局签发的《受理通知书》(受理号:CXHS2000030国),公司申报的盐酸埃克替尼(商品名:凯美纳®,下称“埃克替尼”)用于术后辅助治疗的新适应症上市许可申请已获国家药品监督管理局受理。

埃克替尼是公司自主研发的我国第一个拥有自主知识产权的小分子靶向抗癌药,其疗效确切、肝毒性低、安全性高,循证医学临床证据丰富,中国人群数据全,在CSCO指南、卫健委诊疗规范及脑转移人群、21-L858R NSCLC患者中获优先推荐,也是目前唯一继续开展后续免费用药项目的一代EGFR-TKI原研药,具有明显的差异化优势。

目前,埃克替尼拥有两项适应症:①单药适用于治疗表皮生长因子受体(EGFR)基因具有敏感突变的局部晚期或转移性非小细胞肺癌患者的一线治疗;②单药可试用于治疗既往接受过至少一个化疗方案失败后的局部晚期或转移性非小细胞肺癌,既往化疗主要是指以铂类为基础的联合化疗。

此次埃克替尼用于EGFR基因敏感突变的NSCLC患者术后辅助治疗适应症的上市许可申请的依据是EVIDENCE研究,该项研究是针对Ⅱ-IIIA期肺癌EGFR突变患者术后辅助治疗的对照试验,试验组为埃克替尼治疗,对照组为标准辅助化疗。该项目历时近6年,研究结果显示埃克替尼的疗效优于标准辅助化疗,能显著延长患者无病生存期,同时安全性更优。

截至该公告日,国内尚无经批准用于EGFR基因敏感突变NSCLC患者术后辅助治疗的EGFR-TKI靶向药。

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