重磅!贝伐珠单抗适应症扩展获批!

2018-11-13 佚名 罗氏制药

2018 年 10 月, 贝伐珠单抗(商品名安维汀®) 适应症再获突破 ,国家药品监督管理局药品审评中心(CDE)新近批准: 贝伐珠单抗联合 以铂类为基础的化疗 * 用于 不可切除的晚期、转移性或复发性非鳞状细胞非小细胞肺癌患者 的一线治疗。 贝伐珠单抗联合 以氟嘧啶为基础的化疗 适用于 转移性结直肠癌患者 的治疗。

2018 年 10 月, 贝伐珠单抗(商品名安维汀?) 适应症再获突破 ,国家药品监督管理局药品审评中心(CDE)新近批准:

贝伐珠单抗联合 以铂类为基础的化疗 * 用于 不可切除的晚期、转移性或复发性非鳞状细胞非小细胞肺癌患者 的一线治疗。

贝伐珠单抗联合 以氟嘧啶为基础的化疗 适用于 转移性直肠癌患者 的治疗。

多项“真实世界数据”研究助力治疗方案获批

本次贝伐珠单抗采用回顾性研究结果支持扩展 贝伐珠单抗的化药联合治疗方案 获得了批准,这得益于国家药品监督管理局药品审评中心的政策支持 ,在确保科学严谨的同时更加高效。特别值得一提的是,关于晚期非小细胞肺癌NSCLC)的近期的 3 项中国回顾性真实世界的研究结果显示, 新的 贝伐珠单抗 联合治疗方案的疗效和安全性良好 。

如今,真实世界数据已成为医药大数据的重要组成部分,为制药企业、医务人员和医保机构提供了更大更精确的数据样本,使他们能够正确掌握一种药物在真实的临床机构中由真实的医师处方和真实的患者使用时的有效性和不良反应发生率。

贝伐珠单抗自 2004 年首次在美国获批上市以来,已 先后在全球 100 多个国家和地区获批上市 ,用于 直肠癌、非小细胞肺癌乳腺癌等 10 多种肿瘤的治疗 ,其疗效及安全性已得到多项临床试验的证实。

2017 年,贝伐珠单抗 进入国家医保目录 后可及性大大提高,为更多的患者带来了显着的生存获益并极大地改善了患者的生活和治疗状况。

* 注:以铂类为基础的化疗包括:顺铂、卡铂 + 培美曲塞、吉西他滨、白蛋白紫杉醇、紫杉醇、长春瑞滨等常见药物。

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    2018-11-15 xxxx1054

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