{"id":106203,"date":"2019-03-29T00:00:50","date_gmt":"2019-05-17T09:09:03","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/106203\/"},"modified":"2019-05-17T17:09:06","modified_gmt":"2019-05-17T09:09:06","slug":"7158789cfd","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/106203\/","title":{"rendered":"\u76d8\u70b9 | 2019\u5e74\u7b2c\u4e00\u5b63\u5ea6FDA\u6279\u51c6\u7684\u65b0\u836f\u548c\u65b0\u9002\u5e94\u75c7—-\u5c11\u800c\u7cbe"},"content":{"rendered":"
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\u4e0d\u77e5\u4e0d\u89c9\uff0c2019\u5e74\u7684\u7b2c\u4e00\u5b63\u5ea6\u5373\u5c06\u8fc7\u53bb\u3002\u8fd9\u4e09\u4e2a\u6708\u7684FDA\u76f8\u5bf9\u5e73\u9759\uff0c\u6279\u51c6\u6570\u91cf\u4e0d\u591a\uff0c\u4f46\u662f\u91cd\u78c5\u4e0d\u5c11\uff0c\u5728\u809d\u764c\u3001\u80c3\u764c\u3001\u4e09\u9634\u6027\u4e73\u817a\u764c\u548c\u5c0f\u7ec6\u80de\u80ba\u764c\u7b49\u764c\u79cd\uff0c\u53d6\u5f97\u4e86\u91cd\u5927\u8fdb\u5c55\u3002<\/p>\n


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\u5176\u4e2d\uff0c2\u670815\u65e5\uff0cKeytruda\u83b7\u6279\u7684\u65b0\u9002\u5e94\u75c7\u662fKeytruda\u5728\u7f8e\u56fd\u5e02\u573a\u7528\u4e8e\u8f85\u52a9\u6cbb\u7597\u7684\u9996\u6b21\u6279\u51c6<\/strong>\u30023\u67088\u65e5\uff0cFDA\u6279\u51c6Tecentriq\u8054\u5408\u7528\u836f\u7528\u4e8ePD-L1\u9633\u6027\u7684\u8f6c\u79fb\u6027\u4e09\u9634\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u662f\u7b2c\u4e00\u4e2a\u7528\u4e8e\u4e73\u817a\u764c\u7684\u764c\u75c7\u514d\u75ab\u7597\u6cd5<\/strong>\u30023\u670818\u65e5\uff0cFDA\u6279\u51c6Tecentriq\u8054\u5408\u5316\u7597\uff0c\u7528\u4e8e\u5e7f\u6cdb\u671f\u5c0f\u7ec6\u80de\u80ba\u764c\uff08 ES-SCLC\uff09\u7684\u4e00\u7ebf\u6cbb\u7597\uff0c \u662f20\u591a\u5e74\u6765FDA\u6279\u51c6\u7684\u552f\u4e00\u4e00\u4e2aSCLC\u6cbb\u7597\u65b0\u624b\u6bb5<\/strong>\uff0c\u610f\u4e49\u91cd\u5927\u3002\u4e09\u6708\u4efd\uff0c\u5bf9\u4e8e\u7f57\u6c0f\u7684PD-L1\u5355\u6297TECENTRIQ\u6765\u8bf4\u559c\u8baf\u8fde\u8fde\uff0c\u76f8\u7ee7\u5728\u4e73\u817a\u764c\u548c\u5c0f\u7ec6\u80de\u80ba\u764c\u4e00\u7ebf\u6cbb\u7597\u65b9\u9762\u53d6\u5f97\u91cd\u5927\u7a81\u7834\u3002<\/p>\n


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\u4ee5\u4e0b\u662fFDA2019\u5e74\u7b2c\u4e00\u5b63\u5ea6\u6279\u51c6\u7684\u65b0\u836f\u548c\u65b0\u9002\u5e94\u75c7\u76d8\u70b9\uff08\u622a\u6b62\u52303\u670828\u65e5\uff09\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e00\u6708\u4efd<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Cabozantinib<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Cabometyx<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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1\u670814\u65e5\uff0cFDA\u6279\u51c6Cabozantinib\uff08\u5361\u535a\u66ff\u5c3c\uff0cCabometyx\uff09\u7528\u4e8e\u5148\u524d\u63a5\u53d7\u8fc7\u7d22\u62c9\u975e\u5c3c\uff08Nexavar\uff09\u6cbb\u7597\u7684\u809d\u7ec6\u80de\u764c\uff08HCC\uff09\u60a3\u8005\u3002\u5361\u535a\u66ff\u5c3c\u662fExelixis\u7814\u53d1\u7684\u4e00\u79cd\u591a\u9776\u70b9\u7684\u5c0f\u5206\u5b50\u916a\u6c28\u9178\u6fc0\u9176(RTK)\u6291\u5236\u5242\uff0c\u5df2\u77e5\u9776\u70b9\u5305\u62ec\uff1aMET\u3001RET\u3001VEGFR1\u3001VEGFR 2\u3001VEGFR 3\u3001KIT \u3001AXL\u3001FLT-3\u3001TIE-2 \u3001TRKB\u7b49\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b64\u6b21\u83b7\u6279\u662f\u57fa\u4e8eIII\u671fCELESTIAL\u8bd5\u9a8c\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u4f7f\u7528cabozantinib\u6cbb\u7597\u7684\u603b\u751f\u5b58\u671f\uff08OS\uff09\u63d0\u9ad8\u4e862.2\u4e2a\u6708\u3002\u5361\u535a\u66ff\u5c3c\u7684\u4e2d\u4f4dOS\u4e3a10.2\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7684\u4e2d\u4f4dOS\u4e3a8.0\u4e2a\u6708\uff0c\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e24\uff05\u3002\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u4e3a5.2\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7684\u4e3a1.9\u4e2a\u6708\uff0c\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e56\uff05\u3002\u5361\u535a\u66ff\u5c3c\u7ec4\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a4\uff05\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a0.4\uff05\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2\u6708\u4efd<\/strong><\/p>\n


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pembrolizumab<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Keytruda<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2\u670815\u65e5\uff0cFDA\u6279\u51c6PD-1\u6291\u5236\u5242pembrolizumab\uff08Keytruda\uff09\u7528\u4e8e\u5b8c\u5168\u5207\u9664\u540e\u6dcb\u5df4\u7ed3\u53d7\u7d2f\u7684\u9ad8\u98ce\u9669III\u671f\u9ed1\u8272\u7d20\u7624\u60a3\u8005\u7684\u8f85\u52a9\u6cbb\u7597\uff0c\u8fd9\u662f\u7b2c\u4e00\u4e2a\u5bf9\u60a3\u6709IIIA\u671f\uff0cIIIB\u671f\u548cIIIC\u671f\u9ed1\u7d20\u7624\u7684\u60a3\u8005\u8fdb\u884c\u8f85\u52a9\u6cbb\u7597\u7684\u6297PD-1\u7597\u6cd5\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b64\u6b21\u6279\u51c6\u662f\u57fa\u4e8e\u5173\u952e\u7684III\u671fEORTC 1325 \/ KEYNOTE-054\u8bd5\u9a8c\u7684\u7ed3\u679c\uff0c\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u8f85\u52a9Keytruda\u4f7f\u75be\u75c5\u590d\u53d1\u6216\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e43\uff05\u3002\u5728\u4e2d\u4f4d\u968f\u8bbf15\u4e2a\u6708\u540e\uff0cKeytruda\u76841\u5e74\u65e0\u590d\u53d1\u751f\u5b58\uff08RFS\uff09\u7387\u4e3a75.4\uff05\uff0c\u9ad8\u4e8e\u5b89\u6170\u5242\u7ec4\u768461.0\uff05\u3002\u65e0\u8bbaPD-L1\u8868\u8fbe\u6216BRAF\u7a81\u53d8\u72b6\u6001\u5982\u4f55\uff0c\u5747\u89c2\u5bdf\u5230RFS\u76ca\u5904\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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TAS-102<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Lonsurf<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2\u670822\u65e5\uff0cFDA\u6279\u51c6TAS-102 (Lonsurf)\u7528\u4e8e\u6210\u4eba\u8f6c\u79fb\u6027\u80c3\u817a\u764c(\u5305\u62ec\u80c3\u98df\u7ba1\u4ea4\u754c\u6027\u817a\u764c–GEJ)\uff0c\u8fd9\u4e9b\u60a3\u8005\u81f3\u5c11\u63a5\u53d7\u8fc72\u7ebf\u4ee5\u4e0a\u7cfb\u7edf\u6027\u6cbb\u7597\uff0c\u5305\u62ec\u6c1f\u5627\u5576\u3001\u94c2\u7c7b\u3001\u7d2b\u6749\u70f7\u6216\u4f9d\u7acb\u66ff\u5eb7\uff0c\u4ee5\u53caHER2\/\u795e\u7ecf\u9776\u5411\u6cbb\u7597\u3002TAS-102\u7531\u6838\u82f7\u4ee3\u8c22\u6291\u5236\u5242trifluridine\u4e0e\u80f8\u82f7\u78f7\u9178\u5316\u9176\u6291\u5236\u5242tipiracil\u7ec4\u6210\uff0c\u5176\u6838\u5fc3\u7684\u6297\u764c\u6210\u5206\u4f9d\u7136\u662f\u6c1f\u5c3f\u5627\u5576\u7c7b\u884d\u751f\u7269\uff0c\u53ef\u5e72\u6270DNA\u5408\u6210\uff0c\u6291\u5236\u7ec6\u80de\u589e\u6b96\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b64\u6b21\u83b7\u6279\u662f\u57fa\u4e8eIII\u671fTAGS\u8bd5\u9a8c\u7684\u6570\u636e\uff0c\u4e3b\u8981\u7ec8\u70b9\u4e3a\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\uff0c\u63a5\u53d7TAS-102\u548c\u6700\u4f73\u652f\u6301\u6cbb\u7597(BSC)\u7684\u4e2d\u4f4dOS\u4e3a5.7\u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242+BSC\u6cbb\u7597\u7684\u4e2d\u4f4dOS\u4e3a3.6\u4e2a\u6708\uff0c\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e\u4e8631%\u3002\u572812\u4e2a\u6708\u65f6\uff0cTAS-102\u7ec4\u7684OS\u7387\u4e3a21.2%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a13%\u3002\u6b64\u5916\uff0cTAS-102 \u8fd8\u53ef\u5ef6\u957f\u65e0\u8fdb\u5c55\u751f\u5b58\u671f(PFS)\uff0c\u63d0\u9ad8\u75be\u75c5\u63a7\u5236\u7387(DCR)\uff0c\u5b89\u5168\u6027\u53ef\u63a7\u3002 <\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Herceptin Hylecta<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2\u670828\u65e5\uff0cFDA\u6279\u51c6\u76ae\u4e0b\u6ce8\u5c04\u7684\u66f2\u59a5\u73e0\u5355\u6297\u548c\u900f\u660e\u8d28\u9178\u9176,\u5546\u54c1\u540d\u4e3aHerceptin Hylecta\u3002\u6b64\u83b7\u6279\u4ea7\u54c1\u7ed3\u5408\u5316\u7597\uff0c\u53ef\u7528\u4e8e\u6cbb\u7597HER2\u9633\u6027\u7684\u4e73\u817a\u764c\u60a3\u8005\u3002\u8be5\u5236\u5242\u662f\u7531\u66f2\u59a5\u73e0\u5355\u6297\u548c\u91cd\u7ec4\u4eba\u900f\u660e\u8d28\u9178\u9176PH20(\u4e00\u79cd\u5185\u5207\u7cd6\u82f7\u9176)\u6784\u6210\uff0c\u63a8\u8350\u5242\u91cf\u4e3a600 mg\/ 10000\u5355\u4f4d\uff0c\u5373600 mg\u66f2\u59a5\u73e0\u5355\u6297\u548c10000\u5355\u4f4d\u900f\u660e\u8d28\u9178\u9176\uff0c\u5927\u7ea6\u6bcf3\u5468\u76ae\u4e0b\u7ed9\u836f2 – 5\u5206\u949f\uff0c\u8fdc\u8fdc\u4f4e\u4e8e\u6807\u51c6\u9759\u8109\u8f93\u6ce8\u66f2\u59a5\u73e0\u5355\u6297\u768430 – 90\u5206\u949f\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e09\u6708\u4efd<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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atezolizumab<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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TECENTRIQ<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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3\u67088\u65e5\uff0cFDA\u52a0\u901f\u6279\u51c6atezolizumab(TECENTRIQ)\u548cnab-\u7d2b\u6749\u9187(Abraxane)\u8054\u5408\uff0c\u4f5c\u4e3a\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027PD-L1\u9633\u6027\u4e09\u9634\u6027\u4e73\u817a\u764c(TNBC)\u7684\u4e00\u7ebf\u6cbb\u7597\u3002\u6b64\u6b21\u83b7\u6279\u662f\u57fa\u4e8eIII\u671f\u4e34\u5e8a\u7814\u7a76IMpassion130\uff0c\u5728nab-\u7d2b\u6749\u9187\u4e2d\u6dfb\u52a0Tecentriq\u540e\uff0c\u4e0e\u4ec5\u4f7f\u7528nab-\u7d2b\u6749\u9187\u76f8\u6bd4\uff0c\u60a3\u8005\u7684\u8fdb\u5c55\u6216\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e\u8fd140%\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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