{"id":85308,"date":"2019-04-13T00:00:50","date_gmt":"2019-04-17T03:20:01","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/85308\/"},"modified":"2019-04-17T11:20:02","modified_gmt":"2019-04-17T03:20:02","slug":"b8e8bef386","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/85308\/","title":{"rendered":"\u91cc\u7a0b\u7891\uff01FDA\u4eca\u65e5\u52a0\u901f\u6279\u51c6\u9996\u6b3e\u8180\u80f1\u764c\u4e2a\u4f53\u5316\u7597\u6cd5"},"content":{"rendered":"
\n

\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/h1>\n

\u4eca\u65e5\uff0cFDA\u5ba3\u5e03\u52a0\u901f\u6279\u51c6\u5f3a\u751f\u96c6\u56e2\uff08Johnson & Johnson\uff09\u65d7\u4e0b\u6768\u68ee\uff08Janssen\uff09\u516c\u53f8\u5f00\u53d1\u7684Balversa\uff08erdafitinib\uff09\u4e0a\u5e02\uff0c\u6cbb\u7597\u63a5\u53d7\u94c2\u57fa\u5316\u7597\u540e\u75be\u75c5\u4ecd\u7136\u8fdb\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u8180\u80f1\u764c\u6210\u4eba\u60a3\u8005<\/strong>\u3002\u8fd9\u4e9b\u80bf\u7624\u643a\u5e26\u7279\u5b9a\u81f4\u654f\u6027FGFR3<\/em>\u6216FGFR2<\/em>\u57fa\u56e0\u7a81\u53d8\u3002\u60a3\u8005\u9700\u8981\u63a5\u53d7FDA\u6279\u51c6\u7684\u4f34\u968f\u8bca\u65ad\u6765\u786e\u8ba4\u9002\u5408\u63a5\u53d7erdafitinib\u6cbb\u7597\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8fd9\u662fFDA\u6279\u51c6\u7684\u9996\u6b3e\u9488\u5bf9\u8f6c\u79fb\u6027\u8180\u80f1\u764c\u7684\u9776\u5411\u7597\u6cd5<\/strong>\u3002<\/span><\/p>\n


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\"\u91cc\u7a0b\u7891\uff01FDA\u4eca\u65e5\u52a0\u901f\u6279\u51c6\u9996\u6b3e\u8180\u80f1\u764c\u4e2a\u4f53\u5316\u7597\u6cd5\"<\/p>\n

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\u5728\u7f8e\u56fd\uff0c\u8180\u80f1\u764c\u662f\u7b2c6\u5927\u5e38\u89c1\u764c\u75c7\uff0c\u5176\u4e2d\u6700\u5e38\u89c1\u7684\u8180\u80f1\u764c\u4e3a\u5c3f\u8def\u4e0a\u76ae\u764c\u3002\u8180\u80f1\u764c\u901a\u5e38\u4e0e\u60a3\u8005\u8180\u80f1\u6216\u5c3f\u8def\u4e0a\u76ae\u7ec6\u80de\u4e2d\u51fa\u73b0\u7684\u57fa\u56e0\u7a81\u53d8\u76f8\u5173\u3002\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08FGFR\uff09\u4e2d\u51fa\u73b0\u7684\u7a81\u53d8\u51fa\u73b0\u5728\u5927\u7ea6\u4e94\u5206\u4e4b\u4e00\u7684\u590d\u53d1\/\u96be\u6cbb\u6027\u8180\u80f1\u764c\u60a3\u8005\u4e2d\u3002<\/span><\/p>\n


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Erdafitinib\u662f\u4e00\u79cd\u53e3\u670d\u6cdbFGFR\u6291\u5236\u5242<\/span><\/strong>\u3002FGFRs\u662f\u4e00\u4e2a\u53d7\u4f53\u916a\u6c28\u9178\u6fc0\u9176\u5bb6\u65cf\uff0c\u5728\u4e0d\u540c\u80bf\u7624\u4e2d\u51fa\u73b0\u7684\u57fa\u56e0\u7a81\u53d8\u53ef\u4ee5\u5bfc\u81f4\u5b83\u4eec\u88ab\u6fc0\u6d3b\uff0c\u4ece\u800c\u4fc3\u8fdb\u80bf\u7624\u7ec6\u80de\u7684\u751f\u5b58\u548c\u589e\u6b96\u3002Erdafitinib\u66fe\u7ecf\u83b7\u5f97FDA\u6388\u4e88\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff0c\u8be5\u836f\u7269\u7684\u65b0\u836f\u7533\u8bf7\u4e5f\u83b7\u5f97\u4e86\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002<\/span><\/p>\n


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\"\u91cc\u7a0b\u7891\uff01FDA\u4eca\u65e5\u52a0\u901f\u6279\u51c6\u9996\u6b3e\u8180\u80f1\u764c\u4e2a\u4f53\u5316\u7597\u6cd5\"<\/p>\n

\u25b2Erdafitinib\u7684\u5206\u5b50\u7ed3\u6784\u5f0f\uff08\u56fe\u7247\u6765\u6e90\uff1aEd (Edgar181) [Public domain]\uff09<\/span><\/strong><\/h1>\n


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\u8fd9\u4e00\u6279\u51c6\u662f\u57fa\u4e8eerdafitinib\u5728\u5305\u542b87\u540d\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u8180\u80f1\u764c\u60a3\u8005\u76842\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u8868\u73b0\u3002\u8fd9\u4e9b\u60a3\u8005\u643a\u5e26\u7279\u5b9aFGFR3<\/em>\u6216FGFR2<\/em>\u57fa\u56e0\u7a81\u53d8\u3002\u5728\u8fd9\u4e9b\u63a5\u53d7\u8fc7\u5316\u7597\u5e76\u4e14\u75be\u75c5\u7ee7\u7eed\u8fdb\u5c55\u7684\u60a3\u8005\u4e2d\uff0cerdafitinib\u8fbe\u523032.2%\u7684\u603b\u7f13\u89e3\u7387\uff0c\u5176\u4e2d2.3%\u7684\u60a3\u8005\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\u3002<\/strong><\/span>\u60a3\u8005\u5e73\u5747\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u8fbe\u52305.4\u4e2a\u6708<\/span><\/strong>\u3002\u8fd9\u4e9b\u60a3\u8005\u4e2d25%\u63a5\u53d7\u8fc7\u6297PD-L1\/PD-1\u7597\u6cd5\uff0cerdafitinib\u5bf9\u90a3\u4e9b\u5bf9\u6297PD-L1\/PD-1\u7597\u6cd5\u6ca1\u6709\u53cd\u5e94\u7684\u60a3\u8005\u4e5f\u4ea7\u751f\u7597\u6548<\/strong>\u3002<\/span><\/p>\n


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\u201c\u6211\u4eec\u5904\u4e8e\u4e2a\u4f53\u5316\u7597\u6cd5\u548c\u7cbe\u51c6\u7597\u6cd5\u7684\u65f6\u4ee3\uff0c\u6839\u636e\u60a3\u8005\u643a\u5e26\u7684\u7279\u5b9a\u57fa\u56e0\u7a81\u53d8\u63d0\u4f9b\u9776\u5411\u7597\u6cd5\u6b63\u5728\u6210\u4e3a\u6cbb\u7597\u764c\u75c7\u7684\u6807\u51c6\u3002\u4eca\u5929\u7684\u6279\u51c6\u4ee3\u8868\u7740\u7b2c\u4e00\u6b3e\u9488\u5bf9\u643a\u5e26\u7279\u5b9aFGFR<\/em>\u57fa\u56e0\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u8180\u80f1\u764c\u60a3\u8005\u7684\u4e2a\u4f53\u5316\u7597\u6cd5<\/strong>\uff0c\u201dFDA\u80bf\u7624\u5353\u8d8a\u4e2d\u5fc3\u4e3b\u4efbRichard Pazdur\u535a\u58eb\u8bf4\uff1a\u201cFGFRs\u8c03\u8282\u7ec6\u80de\u751f\u957f\u548c\u5206\u88c2\u7b49\u91cd\u8981\u751f\u7406\u8fc7\u7a0b\u3002\u8fd9\u6b3e\u65b0\u836f\u80fd\u591f\u9776\u5411FGFRs\u7684\u7279\u5b9a\u57fa\u56e0\u7a81\u53d8\u3002\u201d<\/span><\/p>\n


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\u6211\u4eec\u795d\u613f\u8fd9\u6b3e\u65b0\u836f\u65e9\u65e5\u4e0a\u5e02\uff0c\u4e3a\u8180\u80f1\u764c\u60a3\u8005\u9020\u798f\uff0c\u4e5f\u9884\u795d\u66f4\u591a\u4e2a\u4f53\u5316\u521b\u65b0\u7597\u6cd5\u80fd\u591f\u4e3a\u60a3\u8005\u63d0\u4f9b\u66f4\u6709\u6548\u3001\u66f4\u5b89\u5168\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/span><\/p>\n


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

[1] FDA approves first targeted therapy for metastatic bladder cancer. Retrieved April 12, 2019, from https:<\/span>\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm635906.htm<\/span><\/p>\n

[2] Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer. Retrieved April 12, 2019, from https:<\/span>\/\/www.jnj.com\/janssen-submits-new-drug-application-to-u-s-fda-seeking-approval-of-erdafitinib-for-the-treatment-of-metastatic-urothelial-cancer<\/span><\/span><\/p>\n


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\u672c\u6587\u6765\u81ea\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><\/p>\n


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\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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