肺癌新药——靶向药Tagrisso在欧盟获批

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Time of issue:2018-07-24 14:00
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(Summary description)英国制药巨头阿斯利康（AstraZeneca）于6月宣布，欧盟委员会（EC）已批准靶向抗癌药Tagrisso（活性成分为osimertinib mesylate，奥西替尼）作为一种单药疗法，一线治疗携带EGFR激活突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。

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肺癌新药——靶向药Tagrisso在欧盟获批

Categories:最新消息
Author:
Origin:
Time of issue:2018-07-24 14:00
Views:

Information

英国制药巨头阿斯利康（AstraZeneca）于6月宣布，欧盟委员会（EC）已批准靶向抗癌药Tagrisso（活性成分为osimertinib mesylate，奥西替尼）作为一种单药疗法，一线治疗携带EGFR激活突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。

研究表明，Tagrisso和标准EGFR-TKI的安全性、耐受性与各药物已知的属性一致。3级及以上不良事件发生率，Tagrisso较标准EGFR-TKI低（34% vs 45%）。

Tagrisso作为第三代EGFR-TKI ：旨在克服一二代EGFR-TKI药物的耐药性，包括罗氏/安斯泰来年销20亿美元的特罗凯（Tarveca）、阿斯利康的易瑞沙（Iressa）、勃林格殷格翰的Gilotrif（afatinib，阿法替尼）。

在美国和欧盟，Tagrisso已经分别于2015年11月和2016年2月获批，成为首个获批上市用于经EGFR-TKI治疗期间或治疗后病情进展的局部晚期或转移性EGFR T790M突变阳性NSCLC的药物。在中国市场，Tagrisso于2017年3月获得CFDA批准，用于相同适应症。T790M突变与TKI获得性耐药有关。今年4月中旬，Tagrisso再获美国FDA批准，单药一线治疗EGFR突变阳性NSCLC。

相关专利信息

美国：

专利名称	专利号	申请日	法律状态
2-(2,4,5-Substituted-Anilino) Pyrimidine Compounds	US8946235	20120725	授权
2-(2,4,5-Substituted-Anilino) Pyrimidine Compounds	US9732058	20141219	授权

中国：

专利名称	专利号	申请日	法律状态
2-(2,4,5-取代苯胺)嘧啶衍生物作为EGFR调谐子用于治疗癌症	CN103702990B	20120725	授权
2-(2,4,5-取代苯胺)嘧啶衍生物作为EGFR调谐子用于治疗癌症	CN104109161B	20120725	授权
取代的N‑(2‑甲氧基‑5‑硝基苯基)嘧啶‑2‑胺化合物及其盐	CN105254616B	20120725	授权
取代的3-氯-N-[3-(嘧啶-2-基氨基)苯基]丙酰胺或其盐	CN105348266B	20120725	授权
取代的4‑甲氧基‑N<base:Sup>3</base:Sup>‑(嘧啶‑2‑基)苯‑1,3‑二胺化合物及其盐	CN105175396B	20120725	授权
取代的N‑(4‑氟‑2‑甲氧基‑5‑硝基苯基)嘧啶‑2‑胺化合物及其盐	CN105198862B	20120725	授权
2-(2,4,5-取代苯胺)嘧啶衍生物作为EGFR调谐子用于治疗癌症	CN104109151B	20120725	授权

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