{"id":54973,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T02:00:17","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e5%88%9a%e5%88%9a%ef%bc%81fda%e6%89%b9%e5%87%86%e8%be%89%e7%91%9e%e6%96%b0%e8%8d%af%ef%bc%8c%e4%b8%80%e7%ba%bf%e6%b2%bb%e7%96%97egfr%e7%aa%81%e5%8f%98%e8%82%ba%e7%99%8c\/"},"modified":"2018-09-30T10:00:20","modified_gmt":"2018-09-30T02:00:20","slug":"%e5%88%9a%e5%88%9a%ef%bc%81fda%e6%89%b9%e5%87%86%e8%be%89%e7%91%9e%e6%96%b0%e8%8d%af%ef%bc%8c%e4%b8%80%e7%ba%bf%e6%b2%bb%e7%96%97egfr%e7%aa%81%e5%8f%98%e8%82%ba%e7%99%8c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/54973\/","title":{"rendered":"\u521a\u521a\uff01FDA\u6279\u51c6\u8f89\u745e\u65b0\u836f\uff0c\u4e00\u7ebf\u6cbb\u7597EGFR\u7a81\u53d8\u80ba\u764c"},"content":{"rendered":"
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\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/p>\n


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\u4eca\u65e5\uff0c\u8f89\u745e\u516c\u53f8\uff08Pfizer\uff09\u516c\u53f8\u5ba3\u5e03\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u8be5\u516c\u53f8\u7684Vizimpro\uff08dacomitinib\uff09\u4f5c\u4e3a\u4e00\u7ebf\u7597\u6cd5\uff0c\u6cbb\u7597\u643a\u5e26EGFR<\/em>\u57fa\u56e0\u5916\u663e\u5b5019\u7f3a\u5931\u6216\u5916\u663e\u5b5021 L858R\u7f6e\u6362\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u3002<\/strong>\u8fd9\u4e9b\u60a3\u8005\u80bf\u7624\u4e2d\u643a\u5e26\u7684\u7a81\u53d8\u90fd\u5df2\u901a\u8fc7FDA\u6279\u51c6\u7684\u8bca\u65ad\u6d4b\u8bd5\u5f97\u5230\u786e\u8ba4\u3002<\/span><\/p>\n


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\"\u521a\u521a\uff01FDA\u6279\u51c6\u8f89\u745e\u65b0\u836f\uff0c\u4e00\u7ebf\u6cbb\u7597EGFR\u7a81\u53d8\u80ba\u764c\"<\/p>\n

<\/span>
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\u80ba\u764c\u662f\u4e16\u754c\u8303\u56f4\u5bfc\u81f4\u764c\u75c7\u6b7b\u4ea1\u7684\u9996\u8981\u539f\u56e0\u4e4b\u4e00\uff0cNSCLC\u5360\u80ba\u764c\u603b\u6570\u768485%\u3002\u636e\u7edf\u8ba175%\u7684NSCLC\u60a3\u8005\u5728\u786e\u8bca\u65f6\u764c\u75c7\u5df2\u7ecf\u8f6c\u79fb\u6216\u5904\u4e8e\u665a\u671f\uff0c\u4ed6\u4eec\u76845\u5e74\u751f\u5b58\u7387\u53ea\u67095%\u3002<\/span>EGFR\u662f\u4e00\u79cd\u5e2e\u52a9\u7ec6\u80de\u751f\u957f\u548c\u5206\u88c2\u7684\u86cb\u767d\u3002\u5f53<\/span>EGFR<\/em>\u57fa\u56e0\u53d1\u751f\u7a81\u53d8\u540e\uff0c\u5b83\u4f1a\u5bfc\u81f4\u86cb\u767d\u8fc7\u5ea6\u6d3b\u8dc3\uff0c\u4ece\u800c\u5bfc\u81f4\u764c\u7ec6\u80de\u7684\u751f\u6210\u3002<\/span>EGFR<\/em>\u57fa\u56e0\u7a81\u53d8\u51fa\u73b0\u572810-35%\u7684NSCLC\u60a3\u8005\u4e2d\uff0c\u6700\u5e38\u89c1\u7684\u6fc0\u6d3b\u6027\u7a81\u53d8\u4e3a\u5916\u663e\u5b5019\u7f3a\u5931\u548c\u5916\u663e\u5b5021 L858R\u7f6e\u6362\uff0c\u5b83\u4eec\u5360\u5df2\u77e5\u6fc0\u6d3b\u6027<\/span>EGFR<\/em>\u7a81\u53d8\u768480%\u3002\u5bf9\u4e8e\u8fd9\u7c7b\u80bf\u7624\u7684\u6cbb\u7597\u4ecd\u7136\u662f\u4e00\u4e2a\u91cd\u5927\u6311\u6218\u3002<\/span><\/p>\n


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Vizimpro\u662f\u8f89\u745e\u516c\u53f8\u5f00\u53d1\u7684\u53e3\u670d\uff0c\u4e0d\u53ef\u9006\u7684\u4eba\u4f53\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08HER\uff09\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u3002\u8be5\u836f\u7269\u83b7\u5f97\u4e86FDA\u6388\u4e88\u7684\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002<\/span><\/p>\n

\"\u521a\u521a\uff01FDA\u6279\u51c6\u8f89\u745e\u65b0\u836f\uff0c\u4e00\u7ebf\u6cbb\u7597EGFR\u7a81\u53d8\u80ba\u764c\"<\/p>\n

<\/span>\u25b2Dacomitinib\u5206\u5b50\u7ed3\u6784\uff08\u56fe\u7247\u6765\u6e90\uff1aBy Ed (Edgar181) [Public domain], from Wikimedia Commons\uff09<\/span><\/strong><\/p>\n


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\u8fd9\u4e00\u6279\u51c6\u662f\u57fa\u4e8eVizimpro\u5728\u540d\u4e3aARCHER 1050\u7684\u968f\u673a\u591a\u4e2d\u5fc3\u56fd\u9645\u6027\u5f00\u653e\u6807\u7b7e3\u671f\u4e34\u5e8a\u7814\u7a76\u7684\u7ed3\u679c\u3002\u603b\u8ba1452\u540d\u60a3\u8005\u88ab\u968f\u673a\u5206\u4e3a\u4e24\u7ec4\uff0c\u63a5\u53d7Vizimpro\u6216\u8005\u6d3b\u6027\u5bf9\u7167\u7684\u6cbb\u7597\u3002\u8be5\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ec8\u70b9\u4e3a\u7531\u72ec\u7acb\u7684\u653e\u5c04\u5b66\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08IRC\uff09\u8bc4\u4f30\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3002\u6839\u636eIRC\u8bc4\u4f30\u7684PFS\uff0cVizimpro\u4e0e\u6d3b\u6027\u5bf9\u7167\u76f8\u6bd4\uff0c\u663e\u8457\u5ef6\u957f\u4e86\u60a3\u8005\u7684\u4e2d\u4f4dPFS\uff08p<0.0001\uff09\u3002Vizimpro\u6cbb\u7597\u7ec4PFS\u4e3a14.7\u4e2a\u6708\uff0895% CI: 11.1, 16.6\uff09\uff0c\u6d3b\u6027\u5bf9\u7167\u7ec4\u4e3a9.2\u4e2a\u6708\uff0895% CI: 9.1, 11.0\uff09\u3002<\/strong><\/span><\/p>\n


<\/strong><\/span><\/p>\n

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\u201c\u643a\u5e26EGFR<\/em>\u57fa\u56e0\u7a81\u53d8\u7684NSCLC\u662f\u4e00\u79cd\u5e38\u89c1\u764c\u75c7\uff0c\u7279\u522b\u662f\u5728\u4e9a\u6d32\u4eba\u7fa4\u4e2d\u3002\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u6700\u7ec8\u5c06\u4e3a\u60a3\u8005\u9020\u798f\uff0c\u201d ARCHER 1050\u7814\u7a76\u7684\u9996\u5e2d\u7814\u7a76\u5458\uff0c\u9999\u6e2f\u4e2d\u6587\u5927\u5b66\u4e34\u5e8a\u80bf\u7624\u5b66\u7cfb\u4e3b\u5e2dTony Mok\u535a\u58eb\u8bf4\uff1a\u201cARCHER 1050\u7684\u8bd5\u9a8c\u7ed3\u679c\uff0c\u610f\u5473\u7740Vizimpro\u5e94\u8be5\u88ab\u8003\u8651\u6210\u4e3a\u643a\u5e26EGFR<\/em>\u7a81\u53d8\u7684NSCLC\u60a3\u8005\u7684\u65b0\u4e00\u7ebf\u7597\u6cd5\u9009\u62e9\u3002\u201d<\/span><\/p>\n


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\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

[1] U.S. FDA Approves VIZIMPRO\u00ae (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer. Retrieved September 27, 2018, from https:\/\/www.businesswire.com\/news\/home\/20180927005974\/en\/U.S.-FDA-Approves-VIZIMPRO%C2%AE-dacomitinib-First-Line-Treatment<\/span><\/p>\n

[2] Dacomitinib. Retrieved September 27, 2018, from https:\/\/www.pfizer.com\/files\/news\/asco\/Dacomitinib_Fact_Sheet.pdf<\/span><\/p>\n


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\u672c\u6587\u6765\u81ea\u836f\u660e\u5eb7\u5fb7\u5fae\u4fe1\u56e2\u961f\uff0c\u6b22\u8fce\u8f6c\u53d1\u5230\u670b\u53cb\u5708\uff0c\u8c22\u7edd\u8f6c\u8f7d\u5230\u5176\u4ed6\u5e73\u53f0\uff1b\u5982\u6709\u5f00\u8bbe\u767d\u540d\u5355\u9700\u6c42\uff0c\u8bf7\u5728\u6587\u7ae0\u5e95\u90e8\u7559\u8a00\uff1b\u5982\u6709\u5176\u4ed6\u5408\u4f5c\u9700\u6c42\uff0c\u8bf7\u8054\u7cfbwuxi_media@wuxiapptec.com<\/span>
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