{"id":2536,"date":"2021-09-07T10:18:42","date_gmt":"2021-09-07T10:18:42","guid":{"rendered":"https:\/\/aceoncology.org\/?p=2536"},"modified":"2022-06-06T03:10:53","modified_gmt":"2022-06-06T03:10:53","slug":"fda-approvals-august-2021","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-approvals-august-2021\/","title":{"rendered":"\u5728\u7f8e\u83b7\u6279\u7684\u80bf\u7624\u65b0\u836f"},"content":{"rendered":"\n<p>\u4eca\u5e748\u6708\uff0cFDA\u6388\u4e885\u9879\u65b0\u9002\u5e94\u75c7\u7528\u4e8e\u764c\u75c7\u60a3\u8005\u7684\u6cbb\u7597\u3002\u6b64\u5916\uff0c\u8be5\u673a\u6784\u5c06\u4e24\u9879\u52a0\u901f\u6279\u51c6\u8f6c\u5316\u4e3a\u5b8c\u5168\u6279\u51c6\uff0c\u5e76\u6279\u51c6\u7b2c3\u5242COVID-19\u75ab\u82d7\u7528\u4e8e\u514d\u75ab\u529f\u80fd\u4f4e\u4e0b\u60a3\u8005\u63a5\u79cd\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u827e\u4f0f\u5c3c\u5e03\u6cbb\u7597\u665a\u671f\u6216\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c<\/strong>\u3002\u5df2\u6279\u51c6\u53e3\u670d\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1\uff08IDH1\uff09\u6291\u5236\u5242\u827e\u4f0f\u5c3c\u5e03\uff08Tibsovo\u00ae\uff0c\u65bd\u7ef4\u96c5\u516c\u53f8\uff09\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684\u643a\u5e26IDH1\u7a81\u53d8\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c\u60a3\u8005\uff0c\u901a\u8fc7FDA\u540c\u65f6\u6279\u51c6\u7684\u68c0\u6d4b\u6280\u672fOncomine Dx Target test\uff08Life Technologies Corp.\uff09\u68c0\u6d4b\u3002\u8be5\u9879\u5ba1\u6279\u662f\u57fa\u4e8e\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001III\u671f<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7523268\/\">ClarIDHy<\/a>\u7814\u7a76\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7eb3\u5165\u4e86185\u4f8b\u65e2\u5f80\u63a5\u53d7\u4e0d\u8d85\u8fc7\u4e24\u79cd\u65b9\u6848\uff0c\u5176\u4e2d\u5305\u62ec\u81f3\u5c11\u4e00\u79cd\u542b\u5409\u897f\u4ed6\u6ee8\u6216\u6c1f\u5c3f\u5627\u5576\u7684\u65b9\u6848\u6cbb\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684IDH-1\u7a81\u53d8\u80c6\u7ba1\u764c\u60a3\u8005\uff0c\u63a5\u53d7\u827e\u4f0f\u5c3c\u5e03\u6216\u5b89\u6170\u5242\u6cbb\u7597\u3002\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u63a5\u53d7\u827e\u4f0f\u5c3c\u5e03\u6cbb\u7597\u7684\u60a3\u8005\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u663e\u8457\u6539\u5584\uff0c\u4e2d\u4f4dPFS\u5206\u522b\u4e3a2.7\u4e2a\u6708\u548c1.4\u4e2a\u6708\uff08\u98ce\u9669\u6bd4[HR]\uff0c0.37\uff1bP &lt; 0.0001\uff09\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c32%\u63a5\u53d7\u827e\u4f0f\u5c3c\u5e03\u6cbb\u7597\u7684\u60a3\u8005\u57286\u4e2a\u6708\u65f6\u4fdd\u6301\u65e0\u8fdb\u5c55\uff0c22%\u572812\u4e2a\u6708\u65f6\u4fdd\u6301\u65e0\u8fdb\u5c55\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u5219\u65e0\u60a3\u8005\u57286\u4e2a\u6708\u548c12\u4e2a\u6708\u65f6\u4fdd\u6301\u65e0\u8fdb\u5c55\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u5c3f\u8def\u4e0a\u76ae\u764c\u514d\u75ab\u68c0\u67e5\u70b9\u6291\u5236\u5242\u9002\u5e94\u75c7\u7684\u8fdb\u5c55<\/strong><br><strong>\u7eb3\u6b66\u5229\u5c24\u5355\u6297\u7528\u4e8e\u5c3f\u8def\u4e0a\u76ae\u764c\u7684\u8f85\u52a9\u6cbb\u7597 &nbsp;<\/strong>\u7eb3\u6b66\u5229\u5c24\u5355\u6297\uff08\u6b27\u72c4\u6c83\u00ae\uff0c\u767e\u65f6\u7f8e\u65bd\u8d35\u5b9d\u516c\u53f8\uff09\u9996\u6b21\u83b7\u5f97FDA\u6279\u51c6\u7528\u4e8e\u63a5\u53d7\u6839\u6cbb\u6027\u5207\u9664\u672f\u540e\u590d\u53d1\u98ce\u9669\u9ad8\u7684\u5c3f\u8def\u4e0a\u76ae\u764c\uff08UC\uff09\u60a3\u8005\u7684\u8f85\u52a9\u6cbb\u7597\u3002\u6765\u81ea\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001III\u671f<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2021.39.6_suppl.391\">CHECKMATE-274<\/a>\u7814\u7a76\u7684\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5242\uff08n = 356\uff09\u76f8\u6bd4\uff0c\u63a5\u53d7\u7eb3\u6b66\u5229\u5c24\u5355\u6297\u8f85\u52a9\u6cbb\u7597\u7684\u60a3\u8005\uff08n = 353\uff09\u7684\u4e2d\u4f4d\u65e0\u75c5\u751f\u5b58\u671f\uff08DFS\uff09\u51e0\u4e4e\u7ffb\u500d\uff0c\u4e2d\u4f4dDFS\u5206\u522b\u4e3a20.8\u4e2a\u6708\u548c10.8\u4e2a\u6708\uff08HR\uff0c0.70\uff1bP = 0.0008\uff09\u3002\u5bf9\u4e8e\u80bf\u7624PD-L1\u22651%\u7684\u60a3\u8005\uff0c\u63a5\u53d7\u7eb3\u6b66\u5229\u5c24\u5355\u6297\u7684\u60a3\u8005\u672a\u8fbe\u5230\u4e2d\u4f4dDFS\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\u7684\u60a3\u8005\u4e3a8.4\u4e2a\u6708\uff08HR\uff0c0.55\uff1bP = 0.0005\uff09<br><br>\u6b64\u5916\uff0cCHECKMATE-274\u7684\u7ed3\u679c\u4e5f\u652f\u6301\u7eb3\u6b66\u5229\u5c24\u5355\u6297\u7528\u4e8e\u665a\u671f\/\u8f6c\u79fb\u6027UC\u60a3\u8005\u7684\u52a0\u901f\u6279\u51c6\u8f6c\u4e3a\u5e38\u89c4\u6279\u51c6\u3002<br><br><strong>\u5e15\u535a\u5229\u73e0\u5355\u6297\u7528\u4e8e\u665a\u671f\u5c3f\u8def\u4e0a\u76ae\u764c\u6cbb\u7597 &nbsp;<\/strong>FDA\u5c06\u4e00\u7ebf\u5e15\u535a\u5229\u73e0\u5355\u6297\uff08\u53ef\u745e\u8fbe\u00ae\uff0c\u9ed8\u6c99\u4e1c\u516c\u53f8\uff09\u7528\u4e8e\u665a\u671fUC\u60a3\u8005\u7684\u52a0\u901f\u6279\u51c6\u8f6c\u5316\u4e3a\u5b8c\u5168\u6279\u51c6\uff0c\u5e76\u4fee\u8ba2\u4e86\u9002\u5e94\u75c7\uff0c\u4ee5\u6db5\u76d6\u4e0d\u9002\u5408\u63a5\u53d7\u4efb\u4f55\u542b\u94c2\u5316\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027UC\u60a3\u8005\u7684\u6cbb\u7597\u3002\u8bf4\u660e\u4e66\u66f4\u65b0\u662f\u57fa\u4e8e3\u671f<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2021.39.6_suppl.439\">KEYNOTE-361<\/a>\u7814\u7a76\u7684\u5206\u6790\uff0c\u5728\u8be5\u8bd5\u9a8c\u4e2d\uff0c\u665a\u671fUC\u60a3\u8005\uff08n = 1010\uff09\u968f\u673a\u63a5\u53d7\u5355\u836f\u5e15\u535a\u5229\u73e0\u5355\u6297\u3001\u5e15\u535a\u5229\u73e0\u5355\u6297 + \u5316\u7597\u6216\u5355\u72ec\u5316\u7597\u3002\u5c3d\u7ba1\u8054\u5408\u6cbb\u7597\u7684PFS\u548cOS\u6539\u5584\u672a\u8fbe\u5230\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u9608\u503c\uff0c\u4f46\u5728\u6570\u503c\u4e0a\u6709\u6240\u6539\u5584\uff0cFDA\u652f\u6301\u8be5\u9879\u9002\u5e94\u75c7\u7684\u66f4\u65b0\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u6297PD-1\u5355\u514b\u9686\u6297\u4f53Dostarlimab\u7528\u4e8e\u9519\u914d\u4fee\u590d\u7f3a\u9677\uff08dMMR\uff09\u665a\u671f\u5b9e\u4f53\u7624\u7684\u6cbb\u7597\u3002<\/strong>dostarlimab-gxly\uff08Jemperli\u00ae\uff0c\u845b\u5170\u7d20\u53f2\u514b\u516c\u53f8\uff09\u83b7\u5f97\u52a0\u901f\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u6cbb\u7597\u671f\u95f4\u6216\u4e4b\u540e\u75be\u75c5\u8fdb\u5c55\u4e14\u6ca1\u6709\u4ee4\u4eba\u6ee1\u610f\u7684\u66ff\u4ee3\u6cbb\u7597\u9009\u62e9\u7684dMMR\u590d\u53d1\u6027\u6216\u665a\u671f\u5b9e\u4f53\u7624\u3002Ventana MMR RxDx panel\uff08Roche AG\uff09\u662f\u4e00\u79cd\u7528\u4e8e\u68c0\u6d4bdMMR\u5b9e\u4f53\u7624\u7684\u4f34\u968f\u8bca\u65ad\u8bd5\u9a8c\uff0c\u540c\u65f6\u83b7\u5f97\u6279\u51c6\u3002\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6027\u3001\u5355\u81c2\u3001\u591a\u961f\u5217\u3001I\u671f<a href=\"https:\/\/d201nm4szfwn7c.cloudfront.net\/5f95dbd7-245e-4e65-9f36-1a99e28e5bba\/3922a943-9035-44b4-a550-c32e215e9728\/3922a943-9035-44b4-a550-c32e215e9728_viewable_rendition__v.pdf?medcommid=REF--ALL-003599\">GARNET\u7814\u7a76<\/a>\u8bc4\u4ef7\u4e86dostarlimab\u7684\u7597\u6548\u3002\u5728209\u4f8b\u63a5\u53d7dostarlimab\u6cbb\u7597\u7684dMMR\u590d\u53d1\u6027\u6216\u665a\u671f\u5b9e\u4f53\u7624\u60a3\u8005\u4e2d\uff0c\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a41.6%\uff0c\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\u4e3a9.1%\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e3a34.7\u4e2a\u6708\uff0c95%\u7684\u60a3\u8005\u51fa\u73b0\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\uff08DoR\uff09\u22656\u4e2a\u6708\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u7f3a\u6c27\u8bf1\u5bfc\u56e0\u5b50\uff08HIF\uff09\u6291\u5236\u5242Belzutifan\u7528\u4e8e\u6cbb\u7597Von Hippel-Landau\uff08VHL\uff09\u75be\u75c5\u76f8\u5173\u764c\u75c7\u3002<\/strong>VHL\u75c5\u662f\u4e00\u79cd\u9057\u4f20\u6027\u75be\u75c5\uff0c\u7531VHL\u57fa\u56e0\u7a81\u53d8\u5f15\u8d77\uff0c\u53ef\u5bfc\u81f4\u5404\u79cd\u5668\u5b98\u53d1\u751f\u80bf\u7624\u3002Belzutifan\uff08Welireg<sup>TM<\/sup>\uff0c\u9ed8\u6c99\u4e1c\u516c\u53f8\uff09\u662f\u9996\u4e2a\u53e3\u670dHIF-2\u03b1\u6291\u5236\u5242\uff0c\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u9700\u8981\u6cbb\u7597\u7684VHL\u76f8\u5173\u7684\u80be\u7ec6\u80de\u764c\uff08RCC\uff09\u3001\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff08CNS\uff09\u8840\u7ba1\u6bcd\u7ec6\u80de\u7624\u6216\u80f0\u817a\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\uff08pNET\uff09\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u4e00\u9879\u6b63\u5728\u8fdb\u884c\u7684\u3001\u5f00\u653e\u6027\u3001<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2021.39.15_suppl.4555\" target=\"_blank\" rel=\"noreferrer noopener\">II\u671f\u7814\u7a76<\/a>\u7684\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7eb3\u5165\u4e8661\u4f8bVHL\u76f8\u5173\u900f\u660e\u7ec6\u80deRCC\uff08ccRCC\uff09\u60a3\u8005\uff0c\u6839\u636eVHL\u79cd\u7cfb\u6539\u53d8\u8bca\u65ad\uff0c\u5e76\u4e14\u81f3\u5c11\u6709\u4e00\u4e2a\u53ef\u6d4b\u91cf\u7684\u5b9e\u4f53\u7624\u4f4d\u4e8e\u80be\u810f\uff0c\u5165\u7ec4\u60a3\u8005\u63a5\u53d7\u4e86belzutifan\u6cbb\u7597\u3002\u66f4\u65b0\u7684ORR\u4e3a49%\uff0c\u672a\u8fbe\u5230\u4e2d\u4f4dDoR\uff1b56%\u7684\u7f13\u89e3\u8005\u7684DoR\u226512\u4e2a\u6708\uff0c\u4e2d\u4f4d\u81f3\u7f13\u89e3\u65f6\u95f4\u4e3a8\u4e2a\u6708\u3002\u5728\u5176\u4ed6VHL\u80bf\u7624\uff08\u5305\u62ecCNS\u8840\u7ba1\u6bcd\u7ec6\u80de\u7624\u6216pNET\uff09\u60a3\u8005\u4e2d\uff0cORR\u5206\u522b\u4e3a63%\u548c83%\uff0c\u672a\u8fbe\u5230\u4e2d\u4f4dDoR\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u4ed1\u4f10\u66ff\u5c3c\u8054\u5408\u5e15\u535a\u5229\u73e0\u5355\u6297\u7528\u4e8e\u6cbb\u7597\u665a\u671fRCC\u3002\u4ed1\u4f10\u66ff\u5c3c\uff08\u4e50\u536b\u739b\u00ae\uff0c\u536b\u6750\u682a\u5f0f\u4f1a\u793e\uff09\u8054\u5408\u5e15\u535a\u5229\u73e0\u5355\u6297\uff08\u53ef\u745e\u8fbe\u00ae\uff0c\u9ed8\u6c99\u4e1c\u516c\u53f8\uff09\u8054\u5408\u6cbb\u7597\u83b7\u6279\u7528\u4e8e\u665a\u671fRCC\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\u3002<\/strong>\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u3001III\u671f<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2021.39.6_suppl.269\">CLEAR\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u652f\u6301\u8be5\u6279\u51c6\u3002\u65e0\u8bbaPD-L1\u80bf\u7624\u8868\u8fbe\u72b6\u6001\u5982\u4f55\uff0c\u665a\u671fccRCC\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u63a5\u53d7\u4ed1\u4f10\u66ff\u5c3c\u8054\u5408 \u5e15\u535a\u5229\u73e0\u5355\u6297\uff08n = 355\uff09\u6216\u8212\u5c3c\u66ff\u5c3c\u5355\u836f\u6cbb\u7597\uff08n = 357\uff09\u3002\u63a5\u53d7\u8054\u5408\u6cbb\u7597\u60a3\u8005\u7684\u4e2d\u4f4dPFS\u662f\u63a5\u53d7\u8212\u5c3c\u66ff\u5c3c\u6cbb\u7597\u60a3\u8005\u76842\u500d\u4ee5\u4e0a\uff0823.9\u4e2a\u6708vs 9.2\u4e2a\u6708\uff1bHR\uff0c0.39\uff1bP &lt; 0.0001\uff09\u3002\u4e24\u7ec4\u5747\u672a\u8fbe\u5230\u4e2d\u4f4dOS\uff08HR\uff0c0.66\uff1bP = 0.0049\uff09\u3002\u8054\u5408\u6cbb\u7597\u7684ORR\u4e3a71%\uff0c\u8212\u5c3c\u66ff\u5c3c\u4e3a36%\uff08P &lt; 0.0001\uff09\uff0c\u5b8c\u5168\u7f13\u89e3\u7387\u5206\u522b\u4e3a16%\u548c4%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u80bf\u7624\u60a3\u8005\u7b2c\u4e09\u6b21<\/strong><strong>COVID-19<\/strong><strong>\u75ab\u82d7\u63a5\u79cd\u7684\u7d27\u6025\u4f7f\u7528\u6388\u6743<\/strong>\u3002<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised\">\u6839\u636e\u7f8e\u56fd\u75be\u75c5\u63a7\u5236\u548c\u9884\u9632\u4e2d\u5fc3\uff08CDC\uff09\u7684\u4e34\u5e8a\u5efa\u8bae<\/a>\uff0cFDA\u4fee\u6539\u4e86Pfizer-BioNTech\u548cModerna COVID-19\u75ab\u82d7\u7684<a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/recommendations\/immuno.html\">\u7d27\u6025\u4f7f\u7528\u6388\u6743<\/a>\uff0c\u5141\u8bb8\u5728\u4e00\u4e9b\u514d\u75ab\u529f\u80fd\u4f4e\u4e0b\u7684\u60a3\u8005\u4e2d\u4f7f\u7528\u989d\u5916\u7684\u75ab\u82d7\u5242\u91cf\uff0c\u5305\u62ec\u56e0\u5b9e\u4f53\u7624\u6216\u8840\u6db2\u80bf\u7624\u800c\u63a5\u53d7\u79ef\u6781\u7684\u764c\u75c7\u6cbb\u7597\u7684\u60a3\u8005\u3002\u7b2c\u4e09\u5242\u5e94\u5728\u76f8\u540c\u75ab\u82d7\u7684\u4e24\u6b21\u7ed9\u836f\u65b9\u6848\u540e\u81f3\u5c1128\u5929\u6ce8\u5c04\u3002<br><br><strong><\/strong><\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u4eca\u5e748\u6708\uff0cFDA\u6388\u4e885\u9879\u65b0\u9002\u5e94\u75c7\u7528\u4e8e\u764c\u75c7\u60a3\u8005\u7684\u6cbb\u7597\u3002\u6b64\u5916\uff0c\u8be5\u673a\u6784\u5c06\u4e24\u9879\u52a0\u901f\u6279\u51c6\u8f6c\u5316\u4e3a\u5b8c\u5168\u6279\u51c6\uff0c\u5e76\u6279\u51c6\u7b2c3\u5242CO [&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-2536","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>\u5728\u7f8e\u83b7\u6279\u7684\u80bf\u7624\u65b0\u836f - ACE Oncology<\/title>\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-august-2021\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" 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