{"id":5621,"date":"2023-09-20T11:49:00","date_gmt":"2023-09-20T11:49:00","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5621"},"modified":"2023-11-07T14:09:55","modified_gmt":"2023-11-07T14:09:55","slug":"fda-new-cancer-indications-approvals-may-jul-2023","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-may-jul-2023\/","title":{"rendered":"FDA\u57282023\u5e745-7\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>\u7f8e\u56fdFDA\u4e8e2023\u5e745-7\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5728\u8fd9\u4e9b\u65b0\u6279\u51c6\u7684\u7597\u6cd5\u4e2d\uff0c\u4e09\u9879\u9488\u5bf9\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u80bf\u7624\uff0c\u53e6\u5916\u4e24\u9879\u9488\u5bf9\u524d\u5217\u817a\u764c\u3002\u6b64\u5916\uff0c\u4e00\u79cd\u836f\u7269\u88ab\u6279\u51c6\u7528\u4e8e\u5b50\u5bab\u5185\u819c\u764c\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Dostarlimab \u7528\u4e8e\u5b50\u5bab\u5185\u819c\u764c\u3002<\/strong>Dostarlimab-gxly\uff08Jemperli\uff0c\u845b\u5170\u7d20\u53f2\u514b\uff09\u4e0e\u5361\u94c2\u548c\u7d2b\u6749\u9187\u8054\u5408\u7ed9\u836f\u540e\u7ee7\u7eed\u8fdb\u884cdostarlimab-gxly\u5355\u836f\u6cbb\u7597\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-dostarlimab-gxly-chemotherapy-endometrial-cancer\">\u6279\u51c6<\/a>\u7528\u4e8e\u539f\u53d1\u6027\u665a\u671f\u6216\u590d\u53d1\u6027\u9519\u914d\u4fee\u590d\u7f3a\u9677\uff08dMMR\uff1b\u7531FDA\u6279\u51c6\u7684\u68c0\u6d4b\u65b9\u6cd5\u786e\u8ba4\uff09\u6216\u5fae\u536b\u661f\u9ad8\u5ea6\u4e0d\u7a33\u5b9a\u6027\uff08MSI-H\uff09\u5b50\u5bab\u5185\u819c\u764c\u7684\u6cbb\u7597\u3002\u8fd9\u9879\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7814\u7a76<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2216334\">RUBY<\/a>\uff08NCT03981796\uff09\u7684\u7597\u6548\u6570\u636e\u3002\u7814\u7a76\u4e2d\uff0c\u9884\u5148\u6307\u5b9a122\u4f8b\u60a3\u6709dMMR\/MSI-H\u539f\u53d1\u6027\u665a\u671f\u6216\u590d\u53d1\u6027\u5b50\u5bab\u5185\u819c\u764c\u7684\u60a3\u8005\u4e3a\u60a3\u8005\u4e9a\u7ec4\u3002\u5728dMMR\/MSI-H\u4eba\u7fa4\u4e2d\uff0cdostarlimab\u7ec4\u7814\u7a76\u8005\u89c2\u5bdf\u7684\u4e2d\u4f4dPFS\u4e3a30.3\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a7.7\u4e2a\u6708\uff0cHR=0.29\uff0895%CI\uff1a0.17-0.50\uff1b<em>P<\/em>&lt;0.0001\uff09\u3002\u5728\u8be5\u4e9a\u7ec4\u4e2d\uff0cdostarlimab\u7ec42\u5e74PFS\u4e3a61.4%\uff0895%CI\uff1a46.3-73.4\uff09\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a15.7%\uff0895%CI\uff1a7.2-27.0\uff09\uff0c\u8fdb\u5c55\u6216\u6b7b\u4ea1HR=0.28\uff0895%CI\uff1a0.16-0.50\uff1b<em>P<\/em>&lt;0.001\uff09\u3002\u6700\u5e38\u89c1\u7684\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u53cd\u5e94\u4e3a\u6076\u5fc3\u3001\u8131\u53d1\u548c\u75b2\u52b3\uff1b\u5728dostarlimab\u7ec4\uff0c\u5206\u522b\u53d1\u751f\u572853.9%\u300153.5%\u548c51.9%\u7684\u60a3\u8005\u4e2d\uff1b\u5728\u5b89\u6170\u5242\u7ec4\uff0c\u5206\u522b\u53d1\u751f\u572845.9%\u300150.0%\u548c54.5%\u7684\u60a3\u8005\u4e2d\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u4ed6\u62c9\u5511\u5e15\u5229\u8054\u5408\u6069\u6742\u9c81\u80fa\u6cbb\u7597\u540c\u6e90\u91cd\u7ec4\u4fee\u590d\uff08HRR\uff09\u57fa\u56e0\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u6027\u524d\u5217\u817a\u764c\uff08mCRPC\uff09\u3002<\/strong>\u4ed6\u62c9\u5511\u5e15\u5229\uff08Talzenna\uff0c\u8f89\u745e\uff09\u8054\u5408\u6069\u6742\u9c81\u80fa\u6cbb\u7597HRR mCRPC<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate\">\u83b7\u5f97\u6279\u51c6<\/a>\u3002\u8be5\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u961f\u5217\u7814\u7a76<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(23)01055-3\/fulltext\">TALAPRO-2<\/a>\uff08NCT03395197\uff09\u7684\u7597\u6548\u6570\u636e\u3002\u8be5\u7814\u7a76\u62db\u52df\u4e86399\u540d\u65e2\u5f80\u63a5\u53d7\u8fc7\u777e\u4e38\u5207\u9664\u672f\u6216\u4fc3\u6027\u817a\u6fc0\u7d20\u91ca\u653e\u6fc0\u7d20\u7c7b\u4f3c\u7269\u6cbb\u7597\u7684HRR\u57fa\u56e0\u7a81\u53d8\u7684mCRPC\u60a3\u8005\u3002\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u5230\u4ed6\u62c9\u5511\u5e15\u5229\u7ec4\u6216\u5b89\u6170\u5242\u7ec4\uff0c\u6b64\u5916\uff0c\u6240\u6709\u60a3\u8005\u5747\u63a5\u53d7\u6069\u6742\u9c81\u80fa\u6cbb\u7597\u3002\u81f3\u8ba1\u5212\u7684\u4e3b\u8981\u5206\u6790\u8282\u70b9\uff0c\u4ed6\u62c9\u5511\u5e15\u5229\u7ec4\u7684\u5f71\u50cf\u5b66PFS\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a24.9\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a24.6\u4e2a\u6708\u3002\u5728HRR\u57fa\u56e0\u7a81\u53d8\u4eba\u7fa4\u4e2d\uff0c\u4ed6\u62c9\u5511\u5e15\u5229\u7ec4\u672a\u8fbe\u5230\u4e2d\u4f4d\u5f71\u50cf\u5b66PFS\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u7684\u4e2d\u4f4d\u5f71\u50cf\u5b66PFS\u4e3a13.8\u4e2a\u6708\uff08HR=0.45\uff1b95%CI\uff1a0.33-0.61\uff1b<em>P<\/em>&lt;0.0001\uff09\u3002\u5728BRCA\u7a81\u53d8\u7684mCRPC\u60a3\u8005\uff08n=155\uff09\u4e2d\uff0c\u5f71\u50cf\u5b66PFS HR=0.20\uff0895%CI\uff1a0.11-0.36\uff09\u3002\u5728\u672a\u53d1\u751fBRCA\u7a81\u53d8\u4f46HRR\u57fa\u56e0\u7a81\u53d8\u7684mCRPC\u60a3\u8005\u4e2d\uff0c\u5f71\u50cf\u5b66PFS HR=0.72\uff0895%CI\uff1a0.49-1.07\uff09\u3002\u6700\u5e38\u89c1\u76843-4\u7ea7\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u53cd\u5e94\u4e3a\u8d2b\u8840\uff08398\u4f8b\u60a3\u8005\u4e2d\u6709185\u4f8b\uff1b46%\uff09\uff0c\u5242\u91cf\u51cf\u5c11\u540e\u6709\u6240\u6539\u5584\uff1b\u53ea\u670933\u4f8b\u60a3\u8005\uff088%\uff09\u56e0\u8d2b\u8840\u800c\u505c\u7528\u4ed6\u62c9\u5511\u5e15\u5229\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u5965\u62c9\u5e15\u5229\u8054\u5408\u963f\u6bd4\u7279\u9f99\u548c\u6cfc\u5c3c\u677e\u6cbb\u7597BRCA\u7a81\u53d8\u7684 mCRPC<\/strong>\u3002\u5965\u62c9\u5e15\u5229\uff08\u5229\u666e\u5353\uff0c\u963f\u65af\u5229\u5eb7\uff09\u8054\u5408\u963f\u6bd4\u7279\u9f99\u548c\u6cfc\u5c3c\u677e\u9f99\u7528\u4e8e\u7531FDA\u6279\u51c6\u7684\u4f34\u968f\u8bca\u65ad\u68c0\u6d4b\u786e\u8ba4\u7684\u6709\u5bb3\u6216\u7591\u4f3c\u6709\u5bb3\u7684BRCA\u7a81\u53d8\uff08BRCAm\uff09mCRPC\u60a3\u8005<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-olaparib-abiraterone-and-prednisone-or-prednisolone-brca-mutated-metastatic-castration\">\u83b7\u5f97\u6279\u51c6<\/a>\u3002\u53cc\u76f23\u671f\u7814\u7a76<a href=\"https:\/\/evidence.nejm.org\/doi\/full\/10.1056\/EVIDoa2200043\">PROpel<\/a>\uff08NCT03732820\uff09\u7684\u7597\u6548\u6570\u636e\u4e3a\u8be5\u6279\u51c6\u63d0\u4f9b\u4e86\u57fa\u7840\u3002PROp &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\u6cbb\u7597mCRPC\u60a3\u8005\u4e2d\u8fdb\u884c\u4e86\u963f\u6bd4\u7279\u9f99\u8054\u5408\u5965\u62c9\u5e15\u5229\u548c\u963f\u6bd4\u7279\u9f99\u8054\u5408\u5b89\u6170\u5242\u7684\u6bd4\u8f83\u3002\u6839\u636e\u7814\u7a76\u8005\u7684\u89c2\u5bdf\uff0c\u5728\u610f\u5411\u6cbb\u7597\uff08ITT\uff09\u4eba\u7fa4\u4e2d\uff0c\u4e0e\u5b89\u6170\u5242\u8054\u5408\u963f\u6bd4\u7279\u9f99\u76f8\u6bd4\uff0c\u5965\u62c9\u5e15\u5229\u8054\u5408\u963f\u6bd4\u7279\u9f99\u7684\u5f71\u50cf\u5b66PFS\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u6539\u5584\u3002\u5728\u4e3b\u8981\u62a5\u544a\u4e2d\uff0c711\u4f8b\u60a3\u8005\uff08\u5360ITT\u4eba\u7fa4\u768489%\uff09\u6ca1\u6709BRCAm\uff0c\u5f71\u50cf\u5b66PFS HR=0.77\uff0895%CI\uff1a0.63-0.96\uff09\uff0cOS HR=0.92\uff0895%CI\uff1a0.74-1.14\uff09\u3002FDA\u53d1\u73b0\uff0c\u5728ITT\u4eba\u7fa4\u4e2d\u89c2\u5bdf\u5230\u7684\u5f71\u50cf\u5b66PFS\u6539\u5584\u53ef\u80fd\u4e3b\u8981\u5f52\u56e0\u4e8eBRCAm\u60a3\u8005\u3002\u572885\u4f8bBRCAm\u60a3\u8005\uff08\u5360ITT\u4eba\u7fa4\u768411%\uff09\u7684\u63a2\u7d22\u6027\u4e9a\u7ec4\u4e2d\uff0c\u5965\u62c9\u5e15\u5229\u8054\u5408\u6cbb\u7597\u7ec4\u672a\u8fbe\u5230\u4e2d\u4f4d\u5f71\u50cf\u5b66PFS\uff0c\u800c\u5bf9\u7167\u7ec4\u4e3a8\u4e2a\u6708\uff0895%CI\uff1a6-15\uff09\uff0c\u5f71\u50cf\u5b66PFS HR=0.24\uff0895%CI\uff1a0.12-0.45\uff09\uff0cOS HR=0.30\uff0895%CI\uff1a0.15-0.59\uff09\u3002\u5728<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2023.41.6_suppl.LBA16\">\u6700\u7ec8\u7684OS\u6570\u636e\u5206\u6790<\/a>\u4e2d\uff0c\u7814\u7a76\u8005\u53d1\u73b0\uff0c\u5728ITT\u4eba\u7fa4\u4e2d\uff0c\u5965\u62c9\u5e15\u5229\u8054\u5408\u6cbb\u7597\u4e0e\u963f\u6bd4\u7279\u9f99\u7684\u6807\u51c6\u6cbb\u7597\u76f8\u6bd4\uff0c\u5c06OS\u5ef6\u957f\u4e86\u8d85\u8fc77\u4e2a\u6708\u3002\u4e2d\u4f4dOS&gt;42\u4e2a\u6708\uff0c\u662f\u8fc4\u4eca\u4e3a\u6b62\u5728\u4e00\u7ebf\u6cbb\u7597mCRPC\u76843\u671f\u7814\u7a76\u4e2d\u62a5\u544a\u7684\u6700\u957f\u4e2d\u4f4dOS\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Quizartinib\u6cbb\u7597\u6025\u6027\u9ad3\u7cfb\u767d\u8840\u75c5\uff08AML\uff09\u3002<\/strong>Quizartinib\uff08Vanflyta\uff0c\u7b2c\u4e00\u4e09\u5171\uff09<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2023.41.6_suppl.LBA16\">\u83b7\u6279<\/a>\u4e0e\u6807\u51c6\u963f\u7cd6\u80de\u82f7\u548c\u84bd\u73af\u7c7b\u836f\u7269\u8bf1\u5bfc\u4ee5\u53ca\u963f\u7cd6\u80de\u82f7\u5de9\u56fa\u6cbb\u7597\u8054\u5408\u7528\u4e8e\u6cbb\u7597\u65b0\u8bca\u65ad\u7684AML\u6210\u4eba\u60a3\u8005\uff1bQuizartinib\u4e5f\u88ab\u6279\u51c6\u7528\u4e8e\u65b0\u8bca\u65ad\u7684AML\u5de9\u56fa\u5316\u7597\u540e\u7684\u7ef4\u6301\u6027\u5355\u836f\u6cbb\u7597\u3002\u5fc5\u987b\u4f7f\u7528FDA\u6279\u51c6\u7684\u68c0\u6d4b\u6765\u786e\u8ba4AML\u4e3a<em>FLT3<\/em>\u5185\u90e8\u4e32\u8054\u590d\u5236\uff08ITD\uff09\u9633\u6027\u3002FDA\u8fd8\u6279\u51c6\u4e86LeukoStrat CDx FLT3\u7a81\u53d8\u68c0\u6d4b\u4f5c\u4e3aquizartinib\u7684\u4f34\u968f\u8bca\u65ad\u3002FDA\u7684\u8fd9\u9879\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(23)00464-6\/fulltext\">QuANTUM-First<\/a>\uff08NCT02668653\uff09\u7684\u7597\u6548\u6570\u636e\u3002\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u63a5\u53d7quizartinib\u6216\u5b89\u6170\u5242\u52a0\u8bf1\u5bfc\u548c\u5de9\u56fa\u6cbb\u7597\uff0c\u7136\u540e\u6839\u636e\u5176\u521d\u59cb\u5206\u914d\u7684\u65b9\u6848\u8fdb\u884c\u7ef4\u6301\u6027\u5355\u836f\u6cbb\u7597\u3002Quizartinib\u7ec4\u7684\u4e2d\u4f4dOS\u4e3a31.9\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a15.1\u4e2a\u6708\uff08HR=0.78\uff1b95%CI\uff1a0.62-0.98\uff1b\u53cc\u4fa7<em>P<\/em>=0.0324\uff09\u3002\u6bcf\u7ec4\u4e2d\u8d85\u8fc7\u4e00\u534a\u7684\u60a3\u8005\uff0855%\uff09\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\uff0c\u4f46quizartinib\u7ec4\u7684\u4e2d\u4f4d\u6301\u7eed\u65f6\u95f4\u4e3a38.6\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a12.4\u4e2a\u6708\u3002\u4e24\u7ec4\u60a3\u8005\u4e2d\u51e0\u4e4e\u6240\u6709\u60a3\u8005\u90fd\u81f3\u5c11\u53d1\u751f\u8fc7\u4e00\u6b21\u22653\u7ea7\u7684\u4e0d\u826f\u53cd\u5e94\uff08quizartinib\u7ec4\u4e3a92%\uff0cn=244\uff1b\u5b89\u6170\u5242\u7ec4\u4e3a90%\uff0cn=240\uff09\u3002\u6700\u5e38\u89c1\u76843\u7ea7\u62164\u7ea7\u4e0d\u826f\u53cd\u5e94\u4e3a\u53d1\u751f\u5728\u4e24\u7ec4\u4e2d\u7684\u53d1\u70ed\u6027\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u4f4e\u94be\u8840\u75c7\u548c\u80ba\u708e\uff0c\u4ee5\u53caquizartinib\u7ec4\u7684\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3002Quizartinib\u7684\u9ed1\u6846\u8b66\u544a\u63d0\u793aQT\u95f4\u671f\u5ef6\u957f\u3001\u5c16\u7aef\u626d\u8f6c\u578b\u5ba4\u6027\u5fc3\u52a8\u8fc7\u901f\u548c\u5fc3\u810f\u9aa4\u505c\u3002Quizartinib\u53ea\u80fd\u901a\u8fc7Vanflyta\u98ce\u9669\u8bc4\u4f30\u548c\u7f13\u89e3\u7b56\u7565\uff08REMS\uff09\u7684\u53d7\u9650\u8ba1\u5212\u83b7\u5f97\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Glofitamab \u7528\u4e8e\u590d\u53d1\/\u96be\u6cbb\u6027\uff08R\/R\uff09\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u3002<\/strong>Glofitamab-gxbm\uff08Columvi\uff0cGenentech\u516c\u53f8\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u7ecf\u4e24\u7ebf\u6216\u591a\u7ebf\u7cfb\u7edf\u6cbb\u7597\u540e\u7684R\/R\u975e\u7279\u6307\u578b\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08DLBCL\uff09\u6216\u6e90\u4e8e\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\u7684\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08LBCL\uff09\u3002\u8fd9\u9879\u9488\u5bf9CD20\/CD3\u53cc\u7279\u5f02\u6027\u6297\u4f53glofitamab-gxbm\u7684\u6279\u51c6\u4f9d\u636e\u662f\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3\u3001\u5355\u81c2I\/II\u671f\u7814\u7a76<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2206913\">NP30179<\/a>\uff08NCT03075696\uff09\u3002\u5728132\u4f8b\u63a5\u53d7\u7597\u6548\u8bc4\u4f30\u7684\u60a3\u8005\u4e2d\uff0c80%\u60a3\u6709R\/R\u975e\u7279\u6307\u578bDLBCL\uff0c20%\u60a3\u6709\u6e90\u4e8e\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\u7684LBCL\u3002\u5728\u4e2d\u4f4d\u968f\u8bbf12.6\u4e2a\u6708\u65f6\uff0c56%\u7684\u60a3\u8005\uff0895%&nbsp;CI\uff1a47-65\uff09\u8fbe\u5230\u5ba2\u89c2\u7f13\u89e3\uff0c43%\u7684\u60a3\u8005\uff0895%&nbsp;CI\uff1a35-52\uff09\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\u3002\u5e94\u7b54\u60a3\u8005\u7684\u9884\u4f30\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u4e3a18.4\u4e2a\u6708\uff0895%CI\uff1a11.4-NE\uff09\uff0c\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a11.6\u4e2a\u6708\uff1b\u4e2d\u4f4d\u7f13\u89e3\u65f6\u95f4\u4e3a42\u5929\u3002\u5728145\u4f8b\u63a5\u53d7\u5b89\u5168\u6027\u8bc4\u4f30\u7684\u961f\u5217\u4e2d\uff0c\u7ec6\u80de\u56e0\u5b50\u91ca\u653e\u7efc\u5408\u5f81\uff08CRS\uff09\u53d1\u751f\u7387\u4e3a70%\uff08\u22653 \u7ea7CRS\uff1a4.1%\uff09\uff0c\u514d\u75ab\u6548\u5e94\u7ec6\u80de\u76f8\u5173\u795e\u7ecf\u6bd2\u6027\uff08ICANS\uff09\u53d1\u751f\u7387\u4e3a4.8%\uff0c\u4e25\u91cd\u611f\u67d3\u53d1\u751f\u7387\u4e3a16%\uff0c\u71c3\u7624\u53cd\u5e94\u53d1\u751f\u7387\u4e3a12%\u3002\u5904\u65b9\u4fe1\u606f\u5305\u62ec\u4e25\u91cd\u6216\u81f4\u547dCRS\u7684\u9ed1\u6846\u8b66\u544a\u3002\u5176\u4ed6\u8b66\u544a\u548c\u9884\u9632\u63aa\u65bd\u5305\u62ec\u795e\u7ecf\u7cfb\u7edf\u6bd2\u6027\uff0c\u4f8b\u5982ICANS\u3001\u4e25\u91cd\u611f\u67d3\u548c\u71c3\u7624\u53cd\u5e94\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Epcoritamab\u7528\u4e8e R\/R DLBCL\u548c\u9ad8\u7ea7\u522bB\u7ec6\u80de\u6dcb\u5df4\u7624\u3002<\/strong>Epcoritamab-bysp\uff08Epkinly\uff0cGenmab US\u516c\u53f8\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u7ecf\u4e24\u7ebf\u6216\u591a\u7ebf\u7cfb\u7edf\u6cbb\u7597\u540e\u7684R\/R\u975e\u7279\u6307\u578bDLBCL\uff0c\u5305\u62ec\u6e90\u4e8e\u60f0\u6027\u6dcb\u5df4\u7624\u7684DLBCL\uff0c\u4ee5\u53ca\u9ad8\u7ea7\u522bB\u7ec6\u80de\u6dcb\u5df4\u7624\u3002\u8be5\u6279\u51c6\u57fa\u4e8e\u9488\u5bf9R\/R B\u7ec6\u80de\u6dcb\u5df4\u7624\u60a3\u8005\u7684\u5f00\u653e\u6807\u7b7e\u3001\u591a\u961f\u5217\u3001\u591a\u4e2d\u5fc3\u3001\u5355\u81c2\u7814\u7a76EPCORE NHL-1\uff08NCT03625037\uff09\u7684\u7597\u6548\u6570\u636e\u3002\u7597\u6548\u4eba\u7fa4\u5305\u62ec148\u4f8b\u63a5\u53d7\u8fc7\u4e24\u7ebf\u6216\u591a\u7ebf\u7cfb\u7edf\u6cbb\u7597\uff08\u5305\u62ec\u81f3\u5c11\u4e00\u79cd\u542b\u6297 CD20 \u5355\u514b\u9686\u6297\u4f53\u7684\u6cbb\u7597\uff09\u7684R\/R\u975e\u7279\u6307\u578bDLBCL\u60a3\u8005\uff0c\u5305\u62ec\u6e90\u4e8e\u60f0\u6027\u6dcb\u5df4\u7624\u7684DLBCL\uff0c\u4ee5\u53ca\u9ad8\u7ea7\u522bB\u7ec6\u80de\u6dcb\u5df4\u7624\u60a3\u8005\u3002\u5728<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC10115554\/\">\u4e3b\u8981\u62a5\u544a<\/a>\u4e2d\uff0c\u603b\u7f13\u89e3\u7387\u4e3a63.1%\uff0895%CI\uff1a55.0-70.6\uff09\uff0c\u5b8c\u5168\u7f13\u89e3\u7387\u4e3a38.9%\uff0895%CI\uff1a31.2-46.9\uff09\uff1b\u4e2d\u4f4dDOR\u4e3a12.0\u4e2a\u6708\uff08\u5728\u5b8c\u5168\u5e94\u7b54\u60a3\u8005\u4e2d\uff1a\u672a\u8fbe\u5230\uff09\u3002<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2023.41.16_suppl.7525#:~:text=In%20the%20pivotal%20EPCORE%20NHL,%2C%20CD3xCD20%20T%2Dcell%E2%80%93engaging\">\u66f4\u65b0\u6570\u636e<\/a>\u663e\u793a\uff0c\u5728\u66f4\u957f\u65f6\u95f4\u7684\u968f\u8bbf\u540e\uff0cLBCL\u7684\u603b\u7f13\u89e3\u7387\u4e3a63.1%\uff0c\u5b8c\u5168\u7f13\u89e3\u7387\u4e3a39.5%\uff0c\u4e0eDLBCL\u57fa\u672c\u4e00\u81f4\uff0861.9%\u548c39.6%\uff09\u3002\u4e2d\u4f4d\u5b8c\u5168\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u4e3a20.8\u4e2a\u6708\uff0c\u4e2d\u4f4d\u5b8c\u5168\u7f13\u89e3\u65f6\u95f4\u4e3a2.7\u4e2a\u6708\u300251% \u7684\u60a3\u8005\u53d1\u751f\u4e86 CRS\uff0c6% \u7684\u60a3\u8005\u53d1\u751f\u4e86ICANS\uff0c15% \u7684\u60a3\u8005\u53d1\u751f\u4e86\u4e25\u91cd\u611f\u67d3\u3002\u5904\u65b9\u4fe1\u606f\u5305\u62ec\u5bf9\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u7684CRS\u548c\u5371\u53ca\u751f\u547d\u6216\u81f4\u547d\u7684ICANS\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fdFDA\u4e8e2023\u5e745-7\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5728\u8fd9\u4e9b\u65b0\u6279\u51c6\u7684\u7597\u6cd5\u4e2d\uff0c\u4e09\u9879\u9488\u5bf9\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u80bf\u7624\uff0c\u53e6\u5916\u4e24\u9879 [&hellip;]<\/p>\n","protected":false},"author":799,"featured_media":3684,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-5621","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2"],"acf":[],"yoast_head":"<!-- This site is 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