{"id":2821,"date":"2021-10-18T08:20:07","date_gmt":"2021-10-18T08:20:07","guid":{"rendered":"https:\/\/aceoncology.org\/?p=2821"},"modified":"2021-10-18T08:23:26","modified_gmt":"2021-10-18T08:23:26","slug":"fda-approvals-september-2021","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-approvals-september-2021\/","title":{"rendered":"2021\u5e749\u6708\u83b7\u5f97FDA\u6279\u51c6\u7684\u80bf\u7624\u6cbb\u7597"},"content":{"rendered":"\n<p>\u4eca\u5e749\u6708\uff0cFDA\u6388\u4e88\u4e866\u9879\u65b0\u7684\u548c\u6269\u5c55\u7684\u5b9e\u4f53\u7624\u6216\u8840\u6db2\u80bf\u7624\u6cbb\u7597\u7684\u9002\u5e94\u75c7\uff0c\u5176\u4e2d\u4e00\u9879\u7528\u4e8e\u6162\u6027\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\uff08cGVHD\uff09\u60a3\u8005\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Mobocertinib\u7528\u4e8e\u665a\u671fEGFR\u5916\u663e\u5b5020\u63d2\u5165\u7a81\u53d8\u7684NSCLC\u3002<\/strong>Mobocertinib\uff08Exkivity<sup>TM<\/sup>\uff0c\u6b66\u7530\u5236\u836f\uff09\u662f\u4e00\u79cd\u9996\u521b\u7684\u53e3\u670d\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff0c\u9776\u5411\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08EGFR\uff09\u5916\u663e\u5b5020\u63d2\u5165\u7a81\u53d8\uff0c\u83b7\u5f97\u52a0\u901f\u6279\u51c6\uff0c\u7528\u4e8e\u94c2\u7c7b\u836f\u7269\u5316\u7597\u671f\u95f4\u6216\u4e4b\u540e\u75be\u75c5\u8fdb\u5c55\u7684EGFR\u5916\u663e\u5b5020\u63d2\u5165\u7a81\u53d8\u7684\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u3002\u6b64\u9879\u83b7\u6279\u57fa\u4e8e\u56fd\u9645\u3001\u975e\u968f\u673a\u3001\u5f00\u653e\u6027\u3001\u591a\u961f\u5217<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2021.39.15_suppl.9014\">I\/II\u671f\u7684101\u7814\u7a76<\/a>\uff0c\u8be5\u7814\u7a76\u663e\u793a\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a28%\uff0c\u4e2d\u4f4d\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\u4e3a17.5\u4e2a\u6708\uff0c\u4f34\u968f\u8bca\u65adOncomine Dx Target Test\uff08\u8d5b\u9ed8\u98de\u4e16\u5c14\u79d1\u6280\uff09\u540c\u65f6\u83b7\u6279\u7528\u4e8e\u665a\u671fNSCLC\u60a3\u8005\u7684EGFR\u5916\u663e\u5b5020\u63d2\u5165\u7a81\u53d8\u7684\u68c0\u6d4b\u3002\u5904\u65b9\u4fe1\u606f\u4e2d\u5305\u62ecQTc\u95f4\u671f\u5ef6\u957f\u548c\u5c16\u7aef\u626d\u8f6c\u578b\u5ba4\u6027\u5fc3\u52a8\u8fc7\u901f\u7684\u9ed1\u6846\u8b66\u544a\uff0c\u4ee5\u53ca\u95f4\u8d28\u6027\u80ba\u75c5\/\u80ba\u708e\u3001\u5fc3\u810f\u6bd2\u6027\u548c\u8179\u6cfb\u7684\u8b66\u544a\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u7528\u4e8e\u665a\u671f\u5206\u5316\u578b\u7532\u72b6\u817a\u764c\u3002<\/strong><a>Cabozantinib<\/a>\uff08Cabometyx\uff0cExelixis\u516c\u53f8\uff09\u83b7\u6279\u7528\u4e8e\u65e2\u5f80\u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08VEGFR\uff09\u9776\u5411\u6cbb\u7597\u540e\u8fdb\u5c55\u4e14\u4e0d\u9002\u5408\u653e\u5c04\u6027\u7898\u6cbb\u7597\u6216\u653e\u5c04\u6027\u7898\u96be\u6cbb12\u5c81\u53ca\u4ee5\u4e0a\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5206\u5316\u578b\u7532\u72b6\u817a\u764c\u60a3\u8005\u3002\u8be5\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u4e2d\u5fc3\u3001III\u671f <a href=\"https:\/\/secure.jbs.elsevierhealth.com\/action\/getSharedSiteSession?redirect=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flanonc%2Farticle%2FPIIS1470-2045%2821%2900332-6%2Ffulltext&amp;rc=0\">COSMIC-311 \u7814\u7a76<\/a>\u7684\u7597\u6548\u7ed3\u679c\u3002\u66f4\u65b0\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5b89\u6170\u5242\u6cbb\u7597\u7ec4\u60a3\u8005\u76f8\u6bd4\uff0ccabozantinib\uff08\u56fd\u5185\u8bd1\u4e3a\uff1a\u5361\u535a\u66ff\u5c3c\uff09\u6cbb\u7597\u7ec4\u60a3\u8005\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u663e\u8457\u6539\u5584\uff0811.0\u4e2a\u6708\u4e0e1.9\u4e2a\u6708\uff1bP &lt; 0.0001\uff09\uff0c\u8fd9\u4e0e\u65e2\u5f80\u4ed1\u4f10\u66ff\u5c3c\u548c\/\u6216\u7d22\u62c9\u975e\u5c3c\u66b4\u9732\u65e0\u5173\u3002ORR\u5206\u522b\u4e3a11%\u548c0%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u6297\u4f53\u5076\u8054\u836f\u7269<\/strong><a><strong>tisotumab <\/strong><\/a><strong>vedotin\u7528\u4e8e\u6cbb\u7597\u665a\u671f\u5bab\u9888\u764c\u3002<\/strong>Tisotumab vedotin-tftv\uff08Tivdak<sup>TM<\/sup>\uff0cSeagen\u516c\u53f8\uff09\u662f\u4e00\u79cd\u7ec4\u7ec7\u56e0\u5b50\u5bfc\u5411\u6297\u4f53\u548c\u5fae\u7ba1\u6291\u5236\u5242\u7ed3\u5408\u7269\uff0c\u83b7\u5f97\u4e86\u52a0\u901f\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u5316\u7597\u671f\u95f4\u6216\u5316\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684\u590d\u53d1\/\u8f6c\u79fb\u6027\uff08R\/M\uff09\u5bab\u9888\u764c\u60a3\u8005\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3\u3001\u5355\u7ec4\u3001II\u671f <a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(21)00056-5\/fulltext\">innova TV 204 \u7814\u7a76<\/a>\u7684\u7597\u6548\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u4e2d\uff0c\u65e2\u5f80\u5728R\/M\u80cc\u666f\u4e0b\u63a5\u53d7\u8fc7\u4e0d\u8d85\u8fc72\u79cd\u5168\u8eab\u6cbb\u7597\u65b9\u6848\u4e14\u81f3\u5c11\u63a5\u53d7\u8fc71\u79cd\u542b\u94c2\u5316\u7597\uff08\u90e8\u5206\u60a3\u8005\u8054\u5408\u8d1d\u4f10\u73e0\u5355\u6297\uff09\u65b9\u6848\u7684R\/M\u5bab\u9888\u764c\u60a3\u8005\uff0ctisotumab Vedotin\u6cbb\u7597\u7684ORR\u4e3a24%\uff0c\u5b8c\u5168\u7f13\u89e3\u7387\u4e3a7%\uff0c\u4e2d\u4f4d\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\uff08DoR\uff09\u4e3a8.3\u4e2a\u6708\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u65b0\u578bBruton\u916a\u6c28\u9178\u6fc0\u9176\uff08BTK\uff09\u6291\u5236\u5242\u6cfd\u5e03\u66ff\u5c3c\u83b7\u6279\u4e24\u9879\u9002\u5e94\u75c7\uff0c\u5176\u4e2d\u4e00\u9879\u662f\u8fb9\u7f18\u533a\u6dcb\u5df4\u7624\uff08MZL\uff09\u3002<\/strong>\u6cfd\u5e03\u66ff\u5c3c\uff08Brukinsa\u00ae\uff0c\u767e\u6d4e\u795e\u5dde\uff09\u83b7\u5f97\u52a0\u901f\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u81f3\u5c11\u63a5\u53d7\u8fc7\u4e00\u79cd\u57fa\u4e8e\u6297CD20\u6cbb\u7597\u65b9\u6848\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\uff08R\/R\uff09MZL\u60a3\u8005\u3002<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-zanubrutinib-marginal-zone-lymphoma\">\u8be5\u6279\u51c6<\/a>\u662f\u57fa\u4e8e\u6cfd\u5e03\u66ff\u5c3c\u5355\u836f\u7684\u4e24\u9879\u5f00\u653e\u6027\u3001\u591a\u4e2d\u5fc3\u3001\u5355\u81c2\u7814\u7a76\u7684\u7ed3\u679c\u3002\u6700\u8fd1\u53d1\u8868\u7684<a href=\"https:\/\/clincancerres.aacrjournals.org\/content\/early\/2021\/09\/15\/1078-0432.CCR-21-1704.long\">II \u671f MAGNOLIA<\/a> \u7814\u7a76\uff0c\u7eb3\u5165\u4e86\u81f3\u5c11\u63a5\u53d7\u8fc7\u4e00\u79cd\u57fa\u4e8e\u6297CD20\u6cbb\u7597\u65b9\u6848\u7684\u60a3\u8005\uff0cORR\u4e3a68.2%\uff0c25.8%\u7684\u60a3\u8005\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\uff1b\u4f30\u8ba1\u768412\u4e2a\u6708DoR\u7387\u4e3a93%\uff0c\u672a\u8fbe\u5230\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3002<a href=\"https:\/\/library.ehaweb.org\/eha\/2020\/eha25th\/293654\/a.tedeschi.phase.1.2.study.of.single-agent.zanubrutinib.in.patients.with.html\">I\/II \u671f BGB-3111-AU-003 \u7814\u7a76<\/a>\uff0c\u7eb3\u5165\u4e8620\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684MZL\u60a3\u8005\u7684\uff0cORR\u4e3a80%\uff0cCR\u7387\u4e3a15%\uff0c\u4f30\u8ba1\u768418\u4e2a\u6708DoR\u7387\u4e3a66%\u3002<br><br><strong>\u6cfd\u5e03\u66ff\u5c3c\u83b7\u6279\u7684\u53e6\u4e00\u9879\u9002\u5e94\u75c7\u662f\u534e\u6c0f\u5de8\u7403\u86cb\u767d\u8840\u75c7\uff08WM\uff09\u3002<\/strong>\u8fd9\u662f\u57fa\u4e8e\u57282\u4e2aWM\u60a3\u8005\u961f\u5217\u4e2d\u8bc4\u4ef7\u6cfd\u5e03\u66ff\u5c3c\u7597\u6548\uff08\u57fa\u4e8e\u662f\u5426\u5b58\u5728MYD88 L265P\u7a81\u53d8\uff09\u7684\u968f\u673a\u3001\u6d3b\u6027\u5bf9\u7167\u3001\u5f00\u653e\u6807\u7b7e\u3001III\u671f <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7596850\/\">ASPEN \u8bd5\u9a8c<\/a>\u7684\u7ed3\u679c\u3002\u5728\u7b2c\u4e00\u4e2a\u961f\u5217\u4e2d\uff0cMYD88 L265P\u7a81\u53d8\u7684WM\u60a3\u8005\u968f\u673a\u63a5\u53d7\u6cfd\u5e03\u66ff\u5c3c\u6216\u4f0a\u5e03\u66ff\u5c3c\u6cbb\u7597\u3002\u5728\u7b2c\u4e8c\u4e2a\u961f\u5217\u4e2d\uff0cMYD88\u91ce\u751f\u578b\u6216MYD88\u7a81\u53d8\u7684WM\u60a3\u8005\u5747\u63a5\u53d7\u4e86\u6cfd\u5e03\u66ff\u5c3c\u6cbb\u7597\u3002\u961f\u52171\u60a3\u8005\u63a5\u53d7\u6cfd\u5e03\u66ff\u5c3c\u548c\u4f0a\u5e03\u66ff\u5c3c\u6cbb\u7597\u540e\u7684\u4e3b\u8981\u7f13\u89e3\u7387\uff08MRR\uff1a\u5b8c\u5168\u7f13\u89e3\u3001\u975e\u5e38\u597d\u7684\u90e8\u5206\u7f13\u89e3\u548c\u90e8\u5206\u7f13\u89e3\uff09\u5206\u522b\u4e3a77.5%\u548c78%\uff0c18\u4e2a\u6708\u65f6\u7684\u65e0\u4e8b\u4ef6\u7387\u5206\u522b\u4e3a85%\u548c88%\u3002\u5bf9\u4e8e<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2020.38.15_suppl.e20056\">\u961f\u52172<\/a>\uff0cMRR\u4e3a50%\uff0c12\u4e2a\u6708\u65f6\u7684\u65e0\u4e8b\u4ef6\u7387\u4e3a72.4%\u3002\u8bf7\u6ce8\u610f\uff0c\u6279\u51c6\u662f\u57fa\u4e8e\u6cfd\u5e03\u66ff\u5c3c\u7ec4\u7f13\u89e3\u548c\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\u7684\u975e\u6bd4\u8f83\u6027\u8bc4\u4f30\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Ruxolitinib\u7528\u4e8e\u6162\u6027\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\uff08cGVHD\uff09\u3002<\/strong>\u6162\u6027GVHD\u4ecd\u7136\u662f\u5f02\u57fa\u56e0\u9020\u8840\u7ec6\u80de\u79fb\u690d\u540e\u7684\u4e3b\u8981\u5e76\u53d1\u75c7\u3002\u6839\u636e\u968f\u673a\u3001\u5f00\u653e\u6027\u3001\u591a\u4e2d\u5fc3 <a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2033122?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed\">III \u671f REACH-3 \u8bd5\u9a8c<\/a>\u7684\u7597\u6548\u7ed3\u679c\uff0c\u9009\u62e9\u6027JAK1\/2\u6291\u5236\u5242Ruxolitinib\uff08Jakafi\u00ae\uff0cIncyte\u516c\u53f8\uff09\u83b7\u6279\u7528\u4e8e12\u5c81\u53ca\u4ee5\u4e0a\u60a3\u8005\u63a5\u53d7\u4e00\u7ebf\u6216\u4e8c\u7ebf\u5168\u8eab\u6cbb\u7597\u5931\u8d25\u540e\u7684cGVHD\u3002\u5728\u7814\u7a76\u4e2d\uff0c\u60a3\u8005\u5728\u5f02\u57fa\u56e0\u5e72\u7ec6\u80de\u79fb\u690d\u540e\u63a5\u53d7ruxolitinib\u6216\u6700\u4f73\u53ef\u7528\u6cbb\u7597\uff08BAT\uff09\u6cbb\u7597\u76ae\u8d28\u7c7b\u56fa\u9187\u96be\u6cbb\u6027cGVHD\u3002<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-ruxolitinib-chronic-graft-versus-host-disease\">FDA 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