{"id":2940,"date":"2021-11-10T15:08:53","date_gmt":"2021-11-10T15:08:53","guid":{"rendered":"https:\/\/aceoncology.org\/?p=2940"},"modified":"2021-11-10T15:13:12","modified_gmt":"2021-11-10T15:13:12","slug":"fda-approvals-october-2021","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-approvals-october-2021\/","title":{"rendered":"2021\u5e7410\u6708FDA\u80bf\u7624\u65b0\u836f\u5ba1\u6279"},"content":{"rendered":"\n<p>FDA\u6279\u51c6\u4e865\u79cd\u836f\u7269\u7528\u4e8e\u5b9e\u4f53\u7624\u548c\u8840\u6db2\u80bf\u7624\u7684\u6cbb\u7597\uff0c\u5e76\u8ba4\u53ef\u4e86MSKCC\u80bf\u7624\u5206\u5b50\u6807\u5fd7\u7269\u4fe1\u606f\u6570\u636e\u5e93\u7684\u90e8\u5206\u6570\u636e\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u963f\u66ff\u5229\u73e0\u5355\u6297\u4f5c\u4e3aII \u2013 IIIA\u671f NSCLC\u7684\u8f85\u52a9\u6cbb\u7597\u3002<\/strong> \u963f\u66ff\u5229\u73e0\u5355\u6297\uff08\u6cf0\u5723\u5947\u00ae\uff0c\u57fa\u56e0\u6cf0\u514b\/\u7f57\u6c0f\uff09\u83b7\u6279\u7528\u4e8ePD-L1\u8868\u8fbe\u22651%\u80bf\u7624\u7ec6\u80de\u7684II-IIIA\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u624b\u672f\u548c\u94c2\u7c7b\u836f\u7269\u5316\u7597\u540e\u7684\u8f85\u52a9\u6cbb\u7597\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u968f\u673a\u3001\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6027\u3001<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)02098-5\/fulltext\">III\u671fIMpower010\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u3002\u7ed3\u679c\u663e\u793a\uff0c\u5728PD-L1\u8868\u8fbe\u22651%\u80bf\u7624\u7ec6\u80de\u7684II-IIIA\u671fNSCLC\u60a3\u8005\u4e2d\uff0c\u4e0e\u6700\u4f73\u652f\u6301\u6cbb\u7597\u76f8\u6bd4\uff0c\u963f\u66ff\u5229\u73e0\u5355\u6297\u6cbb\u7597\u53ef\u6539\u5584\u65e0\u75c5\u751f\u5b58\u671f\uff08DFS\uff09\uff08\u4e2d\u4f4dDFS\u5206\u522b\u4e3a\u672a\u8fbe\u5230vs. 35.3\u4e2a\u6708\uff1b\u98ce\u9669\u6bd4[HR]\uff0c0.66\uff1bP = 0.0039\uff09\u4f34\u968f\u8bca\u65adVENTANA PD-L1\uff08SP263\uff09\u5e8f\u5217\uff08VENTANA Medical Systems\u516c\u53f8\uff09\u540c\u65f6\u83b7\u6279\u7528\u4e8e\u9009\u62e9\u63a5\u53d7\u963f\u66ff\u5229\u73e0\u5355\u6297\u6cbb\u7597\u7684\u60a3\u8005\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u5e15\u535a\u5229\u73e0\u5355\u6297\u83b7\u6279\u665a\u671f\u5bab\u9888\u764c\u7684\u4e24\u9879\u9002\u5e94\u75c7<\/strong><br><em><strong>\u8054\u5408\u5316\u7597\u00b1\u8d1d\u4f10\u73e0\u5355\u6297\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597<\/strong><\/em><strong>\u3002<\/strong> \u5e15\u535a\u5229\u73e0\u5355\u6297\uff08\u53ef\u745e\u8fbe\u00ae\uff0c\u9ed8\u6c99\u4e1c\uff09\u83b7\u6279\u7528\u4e8e\u8054\u5408\u5316\u7597\u00b1\u8d1d\u4f10\u73e0\u5355\u6297\u4f5c\u4e3aPD-L1\u8868\u8fbe\uff08\u8054\u5408\u9633\u6027\u8bc4\u5206[CPS]\u22651\uff09\u7684\u96be\u6cbb\u6027\u3001\u590d\u53d1\u6027\u6216\u8f6c\u79fb\u6027\u5bab\u9888\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\uff0cPD-L1\u8868\u8fbe\u901a\u8fc7\u4e4b\u524dFDA\u6279\u51c6\u7684\u68c0\u6d4b\u65b9\u6cd5\u786e\u5b9a\u3002\u968f\u673a\u3001\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001III\u671f<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2112435\">KEYNOTE-826\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u652f\u6301\u8be5\u9879\u5ba1\u6279\u3002\u7814\u7a76\u4e2d\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\u7ec4PD-L1\u8868\u8fbe\uff08CPS\u22651\uff09\u60a3\u8005\u7684\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\u672a\u8fbe\u5230\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a16.3\u4e2a\u6708\uff08HR\uff0c0.64\uff1bP = 0.0001\uff09\uff1b\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u5206\u522b\u4e3a10.4\u4e2a\u6708\u548c8.2\u4e2a\u6708\uff08HR\uff0c0.62\uff1bP &lt; 0.0001\uff09\u3002<br><em><strong>\u5355\u836f\u6cbb\u7597 <\/strong><\/em><strong>\u3002<\/strong>\u6839\u636eFDA\u6279\u51c6\u7684\u4f34\u968f\u8bca\u65adPD-L1 IHC 22 C3 pharmDx\uff08Dako North America Inc.\uff09\u7684\u6d4b\u5b9a\u7ed3\u679c\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\u8fd8\u83b7\u5f97\u5e38\u89c4\u6279\u51c6\uff0c\u4f5c\u4e3a\u5316\u7597\u671f\u95f4\u6216\u5316\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684PD-L1\u8868\u8fbe\u60a3\u8005\u7684\u590d\u53d1\u6027\u6216\u8f6c\u79fb\u6027\u5bab\u9888\u764c\u60a3\u8005\u7684\u5355\u836f\u6cbb\u7597\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u963f\u8d1d\u897f\u5229\u8054\u5408\u5185\u5206\u6ccc\u8f85\u52a9\u6cbb\u7597\u9ad8\u5371HR\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u3002<\/strong>\u963f\u8d1d\u897f\u5229\uff08\u552f\u62e9\u00ae\uff0c\u793c\u6765\uff09\u8054\u5408\u5185\u5206\u6ccc\u6cbb\u7597\uff08\u4ed6\u83ab\u6614\u82ac\u6216\u82b3\u9999\u5316\u9176\u6291\u5236\u5242\uff09\u83b7\u6279\u7528\u4e8e\u6fc0\u7d20\u53d7\u4f53\uff08HR\uff09\u9633\u6027\u3001\u4eba\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f532\uff08HER2\uff09\u9634\u6027\u3001\u6dcb\u5df4\u7ed3\u9633\u6027\u3001\u590d\u53d1\u98ce\u9669\u9ad8\u4e14Ki-67\u8bc4\u5206\u226520%\u7684\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u8f85\u52a9\u6cbb\u7597\uff0c\u901a\u8fc7\u540c\u65f6\u6279\u51c6\u7684\u4f34\u968f\u8bca\u65adKi67 IHC MIB-1 pharmDx\uff08Dako Omnis\uff09\u68c0\u6d4b\uff08Agilent\uff0cInc.\uff09\u786e\u5b9a\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u5f00\u653e\u6027\u3001\u968f\u673a\u3001\u53cc\u961f\u5217\u3001\u591a\u4e2d\u5fc3\u3001<a href=\"https:\/\/www.annalsofoncology.org\/action\/showPdf?pii=S0923-7534%2821%2904494-X\">III\u671fmonarchE\u7814\u7a76<\/a>\u7684\u7597\u6548\u7ed3\u679c\uff0c\u5728\u63a5\u53d72\u5e74abemaciclib\u8054\u5408\u6807\u51c6\u5185\u5206\u6ccc\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c36\u4e2a\u6708\u65f6\u7684\u4fb5\u88ad\u6027\u65e0\u75c5\u751f\u5b58\u7387\uff08IDFS\uff09\u4e3a86.1%\uff0c\u800c\u5728\u4ec5\u63a5\u53d7\u5185\u5206\u6ccc\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0cIDFS\u7387\u4e3a79.0%\u3002OS\u6570\u636e\u5c1a\u4e0d\u6210\u719f\uff0c\u968f\u8bbf\u6b63\u5728\u8fdb\u884c\u4e2d\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Brexucabtagene Autoleucel\u83b7\u6279\u7528\u4e8e\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027B\u7ec6\u80de\u524d\u4f53\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u3002<\/strong>CD-19\u9776\u5411\u5d4c\u5408\u6297\u539f\u53d7\u4f53\uff08CAR\uff09T\u7ec6\u80de\u514d\u75ab\u7597\u6cd5brexucabtagene autoleucel\uff08Tecartus\u00ae\uff0cKite Pharma\u516c\u53f8\uff09\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u524d\u4f53B\u7ec6\u80de\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u60a3\u8005\u3002\u5728\u5b8c\u6210\u6dcb\u5df4\u7ec6\u80de\u6e05\u9664\u5316\u7597\u540e\uff0c\u60a3\u8005\u63a5\u53d7brexucabtagene autoleucel\u5355\u6b21\u8f93\u6ce8\u7684\u5355\u7ec4\u3001\u591a\u4e2d\u5fc3ZUMA-3\u7814\u7a76\u4e2d\u8bc4\u4ef7\u4e86\u8fd9\u79cdCAR T\u7ec6\u80de\u6cbb\u7597\u7684\u7597\u6548\u3002\u8be5\u7814\u7a76\u7684<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)01222-8\/fulltext?__cf_chl_jschl_tk__=1HW85.6sDelT1MhtFfJjuXULCODRwYKJLNA.rD7deQ8-1636549879-0-gaNycGzND70\">\u66f4\u65b0\u7ed3\u679c<\/a>\u663e\u793a\uff0c\u5728\u4e2d\u4f4d\u968f\u8bbf16.5\u4e2a\u6708\u65f6\uff0cbrexucabtagene autoleucel\u572870.9%\u7684\u60a3\u8005\u4e2d\u5f15\u8d77\u5b8c\u5168\u7f13\u89e3\/\u5b8c\u5168\u7f13\u89e3\u4f34\u8840\u7ec6\u80de\u8ba1\u6570\u4e0d\u5b8c\u5168\u6062\u590d\uff08CR\/CRi\uff09\uff0c56.4%\u8fbe\u5230CR\u3002\u4e2d\u4f4d\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\u4e3a12.8\u4e2a\u6708\u3002\u540c\u65f6\u8be5\u65b0\u836f\u7684\u5904\u65b9\u4fe1\u606f\u4e2d\uff0c\u5305\u542b\u7ec6\u80de\u56e0\u5b50\u91ca\u653e\u7efc\u5408\u5f81\u548c\u795e\u7ecf\u6bd2\u6027\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Asciminib\u5728 Ph+ CML\u75be\u75c5\u9886\u57df\u83b7\u6279\u4e24\u9879\u9002\u5e94\u75c7: <\/strong>Asciminib\uff08Scemblix\u00ae\uff0c\u8bfa\u534e\uff09\u83b7\u5f97\u52a0\u901f\u5ba1\u6279\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u4e24\u79cd\u6216\u4e24\u79cd\u4ee5\u4e0a\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff08TKI\uff09\u6cbb\u7597\u7684\u6162\u6027\u671f\u8d39\u57ce\u67d3\u8272\u4f53\u9633\u6027\u6162\u6027\u9ad3\u6027\u767d\u8840\u75c5\uff08Ph + CML\uff09\u60a3\u8005\uff0c\u4ee5\u53caT315I\u7a81\u53d8\u6162\u6027\u671fPh + CML\u60a3\u8005\u3002<br><em><strong>\u65e2\u5f80\u63a5\u53d7\u8fc7\u4e24\u79cd\u6216\u4e24\u79cd\u4ee5\u4e0aTKI\u6cbb\u7597\u7684Ph+ CML\u60a3\u8005<\/strong><\/em><strong><em><strong>\u3002<\/strong> <\/em><\/strong>\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u6d3b\u6027\u5bf9\u7167\u3001\u5f00\u653e\u6807\u7b7e\u3001<a href=\"https:\/\/ashpublications.org\/blood\/article\/136\/Supplement_2\/LBA-4\/474191\/Efficacy-and-Safety-Results-from-ASCEMBL-a\">III\u671fASCEMBL\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u3002\u572824\u5468\u65f6\uff0c\u63a5\u53d7asciminib\u6cbb\u7597\u7684\u60a3\u8005\u7684\u4e3b\u8981\u5206\u5b50\u5b66\u7f13\u89e3\uff08MMR\uff09\u4e3a25.5%\uff0c\u63a5\u53d7bosutinib\u6cbb\u7597\u7684\u60a3\u8005\u4e3a13.2%\u3002\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a20\u4e2a\u6708\u65f6\uff0c\u5c1a\u672a\u8fbe\u5230\u4e2d\u4f4dMMR\u6301\u7eed\u65f6\u95f4\u3002<br><em><strong>T315I\u7a81\u53d8\u6162\u6027\u671fPh + CML\u60a3\u8005\u3002<\/strong><\/em>\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6027\u3001<a href=\"https:\/\/ashpublications.org\/blood\/article\/136\/Supplement%201\/47\/470409\/Asciminib-a-First-in-Class-STAMP-Inhibitor\">I\u671fCABL001X2101\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u652f\u6301\u6279\u51c6\u7528\u4e8eT315I\u7a81\u53d8\u60a3\u8005\u3002\u66f4\u65b0\u7ed3\u679c\u663e\u793a\uff0c\u5230\u7b2c24\u5468\uff0c42%\u7684\u60a3\u8005\u8fbe\u5230MMR\uff0c\u5230\u7b2c96\u5468\uff0c49%\u7684\u60a3\u8005\u8fbe\u5230MMR\u3002\u4e2d\u4f4d\u6cbb\u7597\u6301\u7eed\u65f6\u95f4\u4e3a108\u5468\u3002<br><br><strong>MSKCC\u80bf\u7624\u5206\u5b50\u6807\u8bb0\u7269\u4fe1\u606f\u6570\u636e\u5e93\u83b7\u5f97\u8ba4\u53ef<em><strong>\u3002<\/strong><\/em><\/strong><a 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\u963f\u66ff\u5229 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":1803,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[42],"tags":[],"class_list":["post-2940","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-42"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>2021\u5e7410\u6708FDA\u80bf\u7624\u65b0\u836f\u5ba1\u6279 - ACE Oncology<\/title>\n<meta name=\"description\" content=\"10\u6708\u5171\u67095\u9879\u65b0\u7684\u80bf\u7624\u6cbb\u7597\u9002\u5e94\u75c7\u83b7\u5f97FDA\u6279\u51c6\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/aceoncology.org\/zh-hans\/fda-approvals-october-2021\/\" \/>\n<meta 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