{"id":109450,"date":"2024-03-28T13:24:00","date_gmt":"2024-03-28T06:24:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/20240328132400109450"},"modified":"2024-03-29T00:25:16","modified_gmt":"2024-03-28T16:25:16","slug":"cde%e5%8f%97%e7%90%86%e5%ae%89%e6%96%af%e6%b3%b0%e6%9d%a5%e5%92%8c%e8%be%89%e7%91%9e%e7%9a%84ev%e5%b8%95%e5%8d%9a%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%e4%b8%80%e7%ba%bf%e6%b2%bb%e7%96%97%e6%99%9a","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/20240328132400109450","title":{"rendered":"CDE\u53d7\u7406\u5b89\u65af\u6cf0\u6765\u548c\u8f89\u745e\u7684EV+\u5e15\u535a\u5229\u73e0\u5355\u6297\u4e00\u7ebf\u6cbb\u7597\u665a\u671f\u8180\u80f1\u764csBLA"},"content":{"rendered":"<p class=\"prntac\">\u2013\u5173\u952e\u6027\u8bd5\u9a8c\u53d1\u73b0\uff0c\u4e0e\u542b\u94c2\u5316\u7597\u76f8\u6bd4\uff0cenfortumab vedotin \u4e0e&nbsp;pembrolizumab\u8054\u5408\u7597\u6cd5\u663e\u8457\u5ef6\u957f\u4e86\u603b\u751f\u5b58\u671f\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u2013<\/p>\n<p class=\"prntac\">\u2013\u5982\u83b7\u6279\uff0cenfortumab vedotin \u4e0e pembrolizumab\u5c06\u66ff\u4ee3\u5f53\u524d\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u4e00\u7ebf\u6807\u51c6\u7597\u6cd5\u5316\u7597\uff0c\u6210\u4e3a\u4e2d\u56fd\u9996\u4e2a\u66ff\u4ee3\u5316\u7597\u7684\u8054\u5408\u6cbb\u7597\u65b9\u6848<span id=\"spanHghlt61e3\">\u2013<\/span><\/p>\n<p><p><span class=\"legendSpanClass\">\u4e1c\u4eac<\/span><span class=\"legendSpanClass\">2024\u5e743\u670828\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212;&nbsp;\u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\uff08TSE\uff1a4503\uff0c\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\uff1a\u5188\u6751\u76f4\u6811\uff0c&quot;\u5b89\u65af\u6cf0\u6765&quot;\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u5df2\u4e8e2024\u5e743\u670827\u65e5\u53d7\u7406enfortumab vedotin\u4e0epembrolizumab\uff08\u5e15\u535a\u5229\u73e0\u5355\u6297\uff09\u8054\u5408\u7528\u836f\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u65e2\u5f80\u672a\u7ecf\u6cbb\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08la\/mUC\uff09\u6210\u5e74\u60a3\u8005\u7684\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff08sBLA\uff09\u3002\u5982\u83b7\u6279\uff0cenfortumab vedotin \u4e0e pembrolizumab\u8054\u5408\u7528\u836f\u6709\u53ef\u80fd\u6539\u53d8\u73b0\u6709\u7684\u6cbb\u7597\u6a21\u5f0f\uff0c\u6210\u4e3a\u9996\u4e2a\u66ff\u4ee3\u542b\u94c2\u5316\u7597\u7684\u8054\u5408\u7597\u6cd5\uff0c\u540e\u8005\u662f\u76ee\u524dla\/mUC\u7684\u4e00\u7ebf\u6807\u51c6\u7597\u6cd5\u3002<\/p>\n<p>\u5c3f\u8def\u4e0a\u76ae\u764c\uff08UC\uff09\u5305\u62ec\u4e0b\u5c3f\u8def\uff08\u8180\u80f1\u548c\u5c3f\u9053\uff09\u548c\u4e0a\u5c3f\u8def\uff08\u8f93\u5c3f\u7ba1\u548c\u80be\u76c2\uff09\u764c\u75c7\uff0c\u5176\u4e2d\u4e0b\u5c3f\u8def\u764c\u75c7\u5360\u6240\u6709\u5c3f\u8def\u4e0a\u76ae\u764c\u75c5\u4f8b\u768490%\u81f395%\u3002<sup>[i],[ii]<\/sup>\u5168\u7403\u6bcf\u5e74\u7ea6\u670961.4\u4e07\u65b0\u53d1\u8180\u80f1\u764c\u75c5\u4f8b\uff0c\u7ea622\u4e07\u540d\u60a3\u8005\u6b7b\u4e8e\u8180\u80f1\u764c\u3002<sup>[iii]<\/sup>\u636e\u4f30\u8ba1\uff0c2022\u5e74\u4e2d\u56fd\u7ea6\u67099.3\u4e07\u60a3\u8005\u786e\u8bca\u8180\u80f1\u764c\uff0c\u7ea6&nbsp;4.1\u4e07\u540d\u60a3\u8005\u6b7b\u4ea1\u3002<sup>[iv]<\/sup><\/p>\n<p><b>\u5b89\u65af\u6cf0\u6765\u9ad8\u7ea7\u526f\u603b\u88c1\u517c\u80bf\u7624\u5b66\u9886\u57df\u5f00\u53d1\u8d1f\u8d23\u4eba\u3001\u533b\u5b66\u535a\u58eb\u3001\u516c\u5171\u536b\u751f\u7855\u58eb<\/b><b>Ahsan Arozullah<\/b><\/p>\n<p>&quot;\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u662f\u4e00\u79cd\u5371\u53ca\u751f\u547d\u7684\u75be\u75c5\uff0c\u5728\u4e2d\u56fd\u6709\u8fd1\u4e00\u534a\u7684\u786e\u8bca\u60a3\u8005\u6b7b\u4ea1\u3002\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u53d7\u7406enfortumab vedotin\u8054\u5408pembrolizumab\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff0c\u6807\u5fd7\u7740\u6211\u4eec\u5728\u4e3a\u8be5\u60a3\u8005\u7fa4\u4f53\u63d0\u4f9b\u4e34\u5e8a\u6025\u9700\u3001\u521b\u65b0\u6cbb\u7597\u65b9\u6848\u7684\u5f81\u9014\u4e0a\u53c8\u8fc8\u8fdb\u4e86\u4e00\u6b65\u3002&quot;<\/p>\n<p><b>EV-302<\/b><b>\u8bd5\u9a8c\u4e2d\u56fd\u4e3b\u8981\u7814\u7a76\u8005\u3001\u5317\u4eac\u5927\u5b66\u80bf\u7624\u533b\u9662\u9ed1\u8272\u7d20\u7624\u4e0e\u6ccc\u5c3f\u80bf\u7624\u5185\u79d1\u4e3b\u4efb\u3001\u4e2d\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\u526f\u7406\u4e8b\u957f\u517c\u79d8\u4e66\u957f\u90ed\u519b\u6559\u6388<\/b><\/p>\n<p>\u4e2d\u56fd\u665a\u671f\u5c3f\u8def\u4e0a\u76ae\u764c\u76ee\u524d\u7684\u4e00\u7ebf\u6cbb\u7597\u7b56\u7565\u4ecd\u4e3a\u542b\u94c2\u5316\u7597\uff0c\u5c1a\u65e0\u5176\u4ed6\u83b7\u6279\u7684\u4e00\u7ebf\u6cbb\u7597\u65b9\u6848\u3002\u800c\u8fd9\u79cd\u4ee5\u5316\u7597\u4e3a\u4e3b\u7684\u4e00\u7ebf\u6cbb\u7597\u65b9\u6848\u6709\u6548\u7387\u53ca\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u90fd\u6709\u5f85\u8fdb\u4e00\u6b65\u63d0\u9ad8\uff0c\u56e0\u6b64\u4e34\u5e8a\u4e0a\u8feb\u5207\u5730\u9700\u8981\u4e00\u7ebf\u7a81\u7834\u6027\u6cbb\u7597\u65b9\u6848\u7684\u95ee\u4e16\uff0c\u4ee5\u8fdb\u4e00\u6b65\u6539\u5584\u60a3\u8005\u7684\u9884\u540e\u3002EV-302\u7814\u7a76\u7684\u5168\u7403\u6570\u636e\u5960\u5b9a\u4e86enfortumab vedotin\u8054\u5408pembrolizumab\uff0c\u4f5c\u4e3a\u9996\u4e2a\u975e\u542b\u94c2\u5316\u7597\u7684\u4e00\u7ebf\u65b9\u6848\uff0c\u76f8\u6bd4\u5316\u7597\uff0c\u8be5\u6cbb\u7597\u65b9\u6848\u53ef\u4f7f\u6709\u6548\u7387\u8fbe\u5230\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u63d0\u9ad8\u8fd1\u4e00\u500d\uff0c\u5e76\u663e\u8457\u5ef6\u957f\u4e86\u665a\u671f\u5c3f\u8def\u4e0a\u76ae\u764c\u60a3\u8005\u7684\u751f\u5b58\u671f\u3002<\/p>\n<p><b>\u5e7f\u5dde\u4e2d\u5c71\u5927\u5b66\u5b59\u9038\u4ed9\u7eaa\u5ff5\u533b\u9662\u6ccc\u5c3f\u5916\u79d1\u9ec4\u5065\u6559\u6388<\/b><\/p>\n<p>EV-302 \u7684\u5168\u7403\u7814\u7a76\u6570\u636e\u8bc1\u5b9e\u4e86\u5728\u665a\u671f\u5c3f\u8def\u4e0a\u76ae\u764c\u60a3\u8005\u4eba\u7fa4\u4e2d\uff0cenfortumab vedotin\u8054\u5408pembrolizumab\u76f8\u6bd4\u4e8e\u5316\u7597\u7684\u663e\u8457\u6709\u6548\u6027\u4e0e\u5b89\u5168\u6027\uff0c\u662f\u8fc7\u53bb20-30\u5e74\u6765\u9996\u6b21\u4f18\u4e8e\u542b\u94c2\u5316\u7597\u7684\u8054\u5408\u6cbb\u7597\u65b9\u6848\uff0c\u6709\u671b\u6210\u4e3a\u665a\u671f\u5c3f\u8def\u4e0a\u76ae\u764c\u65b0\u7684\u4e00\u7ebf\u6807\u51c6\u6cbb\u7597\u3002\u6211\u4eec\u5e0c\u671b\u5728\u56fd\u5185\u80fd\u5c3d\u65e9\u5f97\u5230\u76d1\u7ba1\u90e8\u95e8\u7684\u6279\u51c6\uff0c\u65e9\u65e5\u60e0\u53ca\u66f4\u591a\u7684\u4e2d\u56fd\u60a3\u8005\u3002<\/p>\n<p>\u6b64\u6b21\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u7684\u8054\u5408\u7528\u836f\u7597\u6cd5sBLA\u662f\u57fa\u4e8e\u4e00\u98793\u671f\u4e34\u5e8a\u8bd5\u9a8cEV-302\uff08\u4e5f\u79f0\u4e3aKEYNOTE-A39\uff09\u7684\u7ed3\u679c\u3002\u8be5\u9879\u7814\u7a76\u53d1\u73b0\uff0c\u8054\u5408\u7597\u6cd5\u53ef\u6539\u5584\u65e2\u5f80\u672a\u7ecf\u6cbb\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08la\/mUC\uff09\u60a3\u8005\u7684\u603b\u751f\u5b58\u671f\uff08OS\uff09\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff0c\u5176\u7ed3\u679c\u5177\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6027\u548c\u4e34\u5e8a\u610f\u4e49\u3002\u5b89\u5168\u6027\u7ed3\u679c\u4e0e\u4e4b\u524d\u62a5\u544a\u7684\u8054\u5408\u7597\u6cd5\u7ed3\u679c\u4e00\u81f4\uff0c\u672a\u53d1\u73b0\u65b0\u7684\u5b89\u5168\u6027\u95ee\u9898\u3002<\/p>\n<p>NMPA \u540c\u65f6\u8fd8\u5728<a href=\"https:\/\/urldefense.com\/v3\/__https:\/www.astellas.com\/en\/news\/27441__;!!JboVxjCXSME!IYCpw8lV8DeRFdFkFkzR5EWVuJhhrwvPz9jzcvmVCjrmjK2MY19wCJQ1v_ThBPNwSV4yNLzIXUZ57Sy6CzywoE4y5s0$\" target=\"_blank\" rel=\"nofollow noopener\">\u5ba1\u6838<\/a>enfortumab vedotin\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7PD-1\/L1\u548c\u542b\u94c2\u5316\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08la\/mUC\uff09\u60a3\u8005\u3002<\/p>\n<p>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09\u4ee5\u53ca\u65e5\u672c<u>\u539a\u751f<\/u><a href=\"https:\/\/www.astellas.com\/en\/news\/28851\" target=\"_blank\" rel=\"nofollow noopener\">\u52b3\u52a8<\/a><u>\u7701<\/u>\uff08MHLW\uff09\u4e5f\u6b63\u5728\u5bf9enfortumab vedotin\u4e0epembrolizumab\u8054\u5408\u7597\u6cd5\u8fdb\u884c<a href=\"https:\/\/www.astellas.com\/en\/news\/28801\" target=\"_blank\" rel=\"nofollow noopener\">\u5ba1\u6838<\/a>\u3002\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09<a href=\"https:\/\/www.astellas.com\/en\/news\/28771\" target=\"_blank\" rel=\"nofollow noopener\">\u5df2\u4e8e2023\u5e7412\u6708\u6279\u51c6\u4e86\u8be5\u8054\u5408\u7597\u6cd5\u3002<\/a>&nbsp;<\/p>\n<p><b>\u9ed1\u6846\u8b66\u544a\uff1a\u4e25\u91cd\u7684\u76ae\u80a4\u53cd\u5e94<\/b><\/p>\n<ul type=\"disc\">\n<li>enfortumab vedotin\u53ef\u5bfc\u81f4\u4e25\u91cd\u548c\u81f4\u547d\u7684\u76ae\u80a4\u4e0d\u826f\u53cd\u5e94\uff0c\u5305\u62ecStevens-Johnson\u7efc\u5408\u5f81\uff08SJS\uff09\u548c\u4e2d\u6bd2\u6027\u8868\u76ae\u574f\u6b7b\u677e\u89e3\u75c7\uff08TEN\uff09\uff0c\u8be5\u7c7b\u76ae\u80a4\u4e0d\u826f\u53cd\u5e94\u4e3b\u8981\u53d1\u751f\u5728\u6cbb\u7597\u7684\u7b2c\u4e00\u5468\u671f\uff0c\u4f46\u5728\u968f\u540e\u5468\u671f\u4ea6\u53ef\u80fd\u53d1\u751f\u3002<\/li>\n<li>\u5bc6\u5207\u76d1\u6d4b\u60a3\u8005\u7684\u76ae\u80a4\u53cd\u5e94\u3002<\/li>\n<li>\u5bf9\u7591\u4f3cSJS\u6216TEN\u6216\u4e25\u91cd\u7684\u76ae\u80a4\u53cd\u5e94\uff0c\u5e94\u7acb\u5373\u505c\u7528enfortumab vedotin\u5e76\u8003\u8651\u8f6c\u8bca\u81f3\u4e13\u4e1a\u62a4\u7406\u3002<\/li>\n<li>\u5bf9\u786e\u8bcaSJS\u6216TEN\uff0c\u6216\u80054\u7ea7\u6216\u590d\u53d1\u60273\u7ea7\u76ae\u80a4\u53cd\u5e94\u60a3\u8005\uff0c\u5e94\u6c38\u4e45\u505c\u7528enfortumab vedotin\u3002<\/li>\n<\/ul>\n<p><b>\u5b89\u65af\u6cf0\u6765\u8b66\u6212\u58f0\u660e<\/b><\/p>\n<p>\u672c\u65b0\u95fb\u7a3f\u4e2d\uff0c\u6709\u5173\u5f53\u524d\u8ba1\u5212\u3001\u4f30\u8ba1\u3001\u6218\u7565\u548c\u4fe1\u5ff5\u4ee5\u53ca\u5176\u4ed6\u975e\u5386\u53f2\u4e8b\u5b9e\u7684\u9648\u8ff0\uff0c\u5747\u4e3a\u5173\u4e8e\u5b89\u65af\u6cf0\u6765\u672a\u6765\u8868\u73b0\u7684\u524d\u77bb\u6027\u9648\u8ff0\u3002\u8fd9\u4e9b\u9648\u8ff0\u662f\u6839\u636e\u7ba1\u7406\u5c42\u7ed3\u5408\u5f53\u524d\u53ef\u83b7\u5f97\u7684\u4fe1\u606f\u800c\u5f62\u6210\u7684\u5f53\u524d\u5047\u8bbe\u548c\u4fe1\u5ff5\u5f97\u51fa\u7684\uff0c\u5e76\u6d89\u53ca\u5df2\u77e5\u548c\u672a\u77e5\u7684\u98ce\u9669\u4e0e\u4e0d\u786e\u5b9a\u6027\u3002\u8bb8\u591a\u56e0\u7d20\u53ef\u80fd\u5bfc\u81f4\u5b9e\u9645\u7ed3\u679c\u4e0e\u524d\u77bb\u6027\u9648\u8ff0\u4e2d\u8ba8\u8bba\u7684\u7ed3\u679c\u4ea7\u751f\u91cd\u5927\u5dee\u5f02\u3002\u8fd9\u4e9b\u56e0\u7d20\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a\uff08i\uff09\u4e0e\u5236\u836f\u5e02\u573a\u6709\u5173\u7684\u4e00\u822c\u7ecf\u6d4e\u6761\u4ef6\u548c\u6cd5\u5f8b\u6cd5\u89c4\u7684\u53d8\u5316\uff0c\uff08ii\uff09\u8d27\u5e01\u6c47\u7387\u6ce2\u52a8\uff0c\uff08iii\uff09\u65b0\u4ea7\u54c1\u4e0a\u5e02\u7684\u5ef6\u8fdf\uff0c\uff08iv\uff09\u5b89\u65af\u6cf0\u6765\u65e0\u6cd5\u6709\u6548\u5730\u9500\u552e\u73b0\u6709\u4ea7\u54c1\u548c\u65b0\u4ea7\u54c1\uff0c\uff08v\uff09\u5b89\u65af\u6cf0\u6765\u65e0\u6cd5\u7ee7\u7eed\u6709\u6548\u5730\u7814\u7a76\u548c\u5f00\u53d1\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5e02\u573a\u4e2d\u88ab\u5ba2\u6237\u63a5\u53d7\u7684\u4ea7\u54c1\uff0c\u4ee5\u53ca\uff08vi\uff09\u7b2c\u4e09\u65b9\u4fb5\u72af\u5b89\u65af\u6cf0\u6765\u7684\u77e5\u8bc6\u4ea7\u6743\u3002<\/p>\n<p>\u672c\u65b0\u95fb\u7a3f\u4e2d\u5305\u542b\u7684\u6709\u5173\u836f\u54c1\uff08\u5305\u62ec\u5f53\u524d\u6b63\u5728\u5f00\u53d1\u7684\u4ea7\u54c1\uff09\u7684\u4fe1\u606f\u5e76\u4e0d\u6784\u6210\u5e7f\u544a\u6216\u533b\u7597\u5efa\u8bae\u3002<\/p>\n<p><sup>[i] <\/sup>Leow JJ, Liu Z, Tan TW, Lee YM, Yeo EK, Chong YL. Optimal Management of Upper Tract Urothelial Carcinoma: Current Perspectives. Onco Targets Ther. 2020;13:1-15.<\/p>\n<p><sup>[ii]<\/sup> Petros FG. Epidemiology, clinical presentation, and evaluation of upper-tract urothelial carcinoma. Transl Androl Urol. 2020;9(4):1794-8.<\/p>\n<p><sup>[iii]<\/sup> International Agency for Research on Cancer.&nbsp;Cancer Today: Bladder Globocan 2022 fact sheet (01-2024). <a href=\"https:\/\/gco.iarc.who.int\/media\/globocan\/factsheets\/cancers\/30-bladder-fact-sheet.pdf\" target=\"_blank\" rel=\"nofollow noopener\">30-bladder-fact-sheet.pdf (who.int)<\/a><\/p>\n<p><sup>[iv]<\/sup> International Agency for Research on Cancer (IARC). Bladder Fact Sheet. <span class=\"xn-location\">Lyon, France<\/span>. 2022 (02-2024). Available at: <a href=\"https:\/\/gco.iarc.who.int\/media\/globocan\/factsheets\/populations\/160-china-fact-sheet.pdf\" target=\"_blank\" rel=\"nofollow noopener\">160-china-fact-sheet.pdf (who.int)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u2013\u5173\u952e\u6027\u8bd5\u9a8c\u53d1\u73b0\uff0c\u4e0e\u542b\u94c2\u5316\u7597\u76f8\u6bd4\uff0cenfortumab vedotin \u4e0e&nbsp;pembrolizumab\u8054\u5408\u7597\u6cd5\u663e\u8457\u5ef6\u957f\u4e86\u603b\u751f\u5b58\u671f\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u2013 \u2013\u5982\u83b7\u6279\uff0cenfortumab vedotin \u4e0e pembrolizumab\u5c06\u66ff\u4ee3\u5f53\u524d\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u4e00\u7ebf\u6807\u51c6\u7597\u6cd5\u5316\u7597\uff0c\u6210\u4e3a\u4e2d\u56fd\u9996\u4e2a\u66ff\u4ee3\u5316\u7597\u7684\u8054\u5408\u6cbb\u7597\u65b9\u6848\u2013 \u4e1c\u4eac2024\u5e743\u670828\u65e5 \/\u7f8e\u901a\u793e\/ &#8212;&nbsp;\u5b89\u65af\u6cf0\u6765\u5236\u836f\u96c6\u56e2\uff08TSE\uff1a4503\uff0c\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\uff1a\u5188\u6751\u76f4\u6811\uff0c&quot;\u5b89\u65af\u6cf0\u6765&quot;\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u5df2\u4e8e2024\u5e743\u670827\u65e5\u53d7\u7406enfortumab vedotin\u4e0epembrolizumab\uff08\u5e15\u535a\u5229\u73e0\u5355\u6297\uff09\u8054\u5408\u7528\u836f\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u65e2\u5f80\u672a\u7ecf\u6cbb\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08la\/mUC\uff09\u6210\u5e74\u60a3\u8005\u7684\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff08sBLA\uff09\u3002\u5982\u83b7\u6279\uff0cenfortumab vedotin \u4e0e pembrolizumab\u8054\u5408\u7528\u836f\u6709\u53ef\u80fd\u6539\u53d8\u73b0\u6709\u7684\u6cbb\u7597\u6a21\u5f0f\uff0c\u6210\u4e3a\u9996\u4e2a\u66ff\u4ee3\u542b\u94c2\u5316\u7597\u7684\u8054\u5408\u7597\u6cd5\uff0c\u540e\u8005\u662f\u76ee\u524dla\/mUC\u7684\u4e00\u7ebf\u6807\u51c6\u7597\u6cd5\u3002 \u5c3f\u8def\u4e0a\u76ae\u764c\uff08UC\uff09\u5305\u62ec\u4e0b\u5c3f\u8def\uff08\u8180\u80f1\u548c\u5c3f\u9053\uff09\u548c\u4e0a\u5c3f\u8def\uff08\u8f93\u5c3f\u7ba1\u548c\u80be\u76c2\uff09\u764c\u75c7\uff0c\u5176\u4e2d\u4e0b\u5c3f\u8def\u764c\u75c7\u5360\u6240\u6709\u5c3f\u8def\u4e0a\u76ae\u764c\u75c5\u4f8b\u768490%\u81f395%\u3002[i],[ii]\u5168\u7403\u6bcf\u5e74\u7ea6\u670961.4\u4e07\u65b0\u53d1\u8180\u80f1\u764c\u75c5\u4f8b\uff0c\u7ea622\u4e07\u540d\u60a3\u8005\u6b7b\u4e8e\u8180\u80f1\u764c\u3002[iii]\u636e\u4f30\u8ba1\uff0c2022\u5e74\u4e2d\u56fd\u7ea6\u67099.3\u4e07\u60a3\u8005\u786e\u8bca\u8180\u80f1\u764c\uff0c\u7ea6&nbsp;4.1\u4e07\u540d\u60a3\u8005\u6b7b\u4ea1\u3002[iv] \u5b89\u65af\u6cf0\u6765\u9ad8\u7ea7\u526f\u603b\u88c1\u517c\u80bf\u7624\u5b66\u9886\u57df\u5f00\u53d1\u8d1f\u8d23\u4eba\u3001\u533b\u5b66\u535a\u58eb\u3001\u516c\u5171\u536b\u751f\u7855\u58ebAhsan Arozullah &quot;\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u662f\u4e00\u79cd\u5371\u53ca\u751f\u547d\u7684\u75be\u75c5\uff0c\u5728\u4e2d\u56fd\u6709\u8fd1\u4e00\u534a\u7684\u786e\u8bca\u60a3\u8005\u6b7b\u4ea1\u3002\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u53d7\u7406enfortumab vedotin\u8054\u5408pembrolizumab\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff0c\u6807\u5fd7\u7740\u6211\u4eec\u5728\u4e3a\u8be5\u60a3\u8005\u7fa4\u4f53\u63d0\u4f9b\u4e34\u5e8a\u6025\u9700\u3001\u521b\u65b0\u6cbb\u7597\u65b9\u6848\u7684\u5f81\u9014\u4e0a\u53c8\u8fc8\u8fdb\u4e86\u4e00\u6b65\u3002&quot; 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\u9ed1\u6846\u8b66\u544a\uff1a\u4e25\u91cd\u7684\u76ae\u80a4\u53cd\u5e94 enfortumab vedotin\u53ef\u5bfc\u81f4\u4e25\u91cd\u548c\u81f4\u547d\u7684\u76ae\u80a4\u4e0d\u826f\u53cd\u5e94\uff0c\u5305\u62ecStevens-Johnson\u7efc\u5408\u5f81\uff08SJS\uff09\u548c\u4e2d\u6bd2\u6027\u8868\u76ae\u574f\u6b7b\u677e\u89e3\u75c7\uff08TEN\uff09\uff0c\u8be5\u7c7b\u76ae\u80a4\u4e0d\u826f\u53cd\u5e94\u4e3b\u8981\u53d1\u751f\u5728\u6cbb\u7597\u7684\u7b2c\u4e00\u5468\u671f\uff0c\u4f46\u5728\u968f\u540e\u5468\u671f\u4ea6\u53ef\u80fd\u53d1\u751f\u3002 \u5bc6\u5207\u76d1\u6d4b\u60a3\u8005\u7684\u76ae\u80a4\u53cd\u5e94\u3002 \u5bf9\u7591\u4f3cSJS\u6216TEN\u6216\u4e25\u91cd\u7684\u76ae\u80a4\u53cd\u5e94\uff0c\u5e94\u7acb\u5373\u505c\u7528enfortumab vedotin\u5e76\u8003\u8651\u8f6c\u8bca\u81f3\u4e13\u4e1a\u62a4\u7406\u3002 \u5bf9\u786e\u8bcaSJS\u6216TEN\uff0c\u6216\u80054\u7ea7\u6216\u590d\u53d1\u60273\u7ea7\u76ae\u80a4\u53cd\u5e94\u60a3\u8005\uff0c\u5e94\u6c38\u4e45\u505c\u7528enfortumab vedotin\u3002 \u5b89\u65af\u6cf0\u6765\u8b66\u6212\u58f0\u660e \u672c\u65b0\u95fb\u7a3f\u4e2d\uff0c\u6709\u5173\u5f53\u524d\u8ba1\u5212\u3001\u4f30\u8ba1\u3001\u6218\u7565\u548c\u4fe1\u5ff5\u4ee5\u53ca\u5176\u4ed6\u975e\u5386\u53f2\u4e8b\u5b9e\u7684\u9648\u8ff0\uff0c\u5747\u4e3a\u5173\u4e8e\u5b89\u65af\u6cf0\u6765\u672a\u6765\u8868\u73b0\u7684\u524d\u77bb\u6027\u9648\u8ff0\u3002\u8fd9\u4e9b\u9648\u8ff0\u662f\u6839\u636e\u7ba1\u7406\u5c42\u7ed3\u5408\u5f53\u524d\u53ef\u83b7\u5f97\u7684\u4fe1\u606f\u800c\u5f62\u6210\u7684\u5f53\u524d\u5047\u8bbe\u548c\u4fe1\u5ff5\u5f97\u51fa\u7684\uff0c\u5e76\u6d89\u53ca\u5df2\u77e5\u548c\u672a\u77e5\u7684\u98ce\u9669\u4e0e\u4e0d\u786e\u5b9a\u6027\u3002\u8bb8\u591a\u56e0\u7d20\u53ef\u80fd\u5bfc\u81f4\u5b9e\u9645\u7ed3\u679c\u4e0e\u524d\u77bb\u6027\u9648\u8ff0\u4e2d\u8ba8\u8bba\u7684\u7ed3\u679c\u4ea7\u751f\u91cd\u5927\u5dee\u5f02\u3002\u8fd9\u4e9b\u56e0\u7d20\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a\uff08i\uff09\u4e0e\u5236\u836f\u5e02\u573a\u6709\u5173\u7684\u4e00\u822c\u7ecf\u6d4e\u6761\u4ef6\u548c\u6cd5\u5f8b\u6cd5\u89c4\u7684\u53d8\u5316\uff0c\uff08ii\uff09\u8d27\u5e01\u6c47\u7387\u6ce2\u52a8\uff0c\uff08iii\uff09\u65b0\u4ea7\u54c1\u4e0a\u5e02\u7684\u5ef6\u8fdf\uff0c\uff08iv\uff09\u5b89\u65af\u6cf0\u6765\u65e0\u6cd5\u6709\u6548\u5730\u9500\u552e\u73b0\u6709\u4ea7\u54c1\u548c\u65b0\u4ea7\u54c1\uff0c\uff08v\uff09\u5b89\u65af\u6cf0\u6765\u65e0\u6cd5\u7ee7\u7eed\u6709\u6548\u5730\u7814\u7a76\u548c\u5f00\u53d1\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5e02\u573a\u4e2d\u88ab\u5ba2\u6237\u63a5\u53d7\u7684\u4ea7\u54c1\uff0c\u4ee5\u53ca\uff08vi\uff09\u7b2c\u4e09\u65b9\u4fb5\u72af\u5b89\u65af\u6cf0\u6765\u7684\u77e5\u8bc6\u4ea7\u6743\u3002 \u672c\u65b0\u95fb\u7a3f\u4e2d\u5305\u542b\u7684\u6709\u5173\u836f\u54c1\uff08\u5305\u62ec\u5f53\u524d\u6b63\u5728\u5f00\u53d1\u7684\u4ea7\u54c1\uff09\u7684\u4fe1\u606f\u5e76\u4e0d\u6784\u6210\u5e7f\u544a\u6216\u533b\u7597\u5efa\u8bae\u3002 [i] Leow JJ, Liu Z, Tan TW, Lee YM, Yeo EK, Chong&hellip; <a class=\"read-more\" href=\"https:\/\/www.xinwengao.com\/cn\/pr\/20240328132400109450\">Read More<\/a><\/p>\n","protected":false},"author":556,"featured_media":0,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1965],"tags":[],"class_list":["post-109450","post","type-post","status-publish","format-standard","hentry","category-partnerships"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/109450","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/comments?post=109450"}],"version-history":[{"count":1,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/109450\/revisions"}],"predecessor-version":[{"id":109451,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/109450\/revisions\/109451"}],"wp:attachment":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media?parent=109450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/categories?post=109450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/tags?post=109450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}