{"id":5218,"date":"2023-02-27T15:49:55","date_gmt":"2023-02-27T15:49:55","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5218"},"modified":"2023-05-24T09:44:46","modified_gmt":"2023-05-24T09:44:46","slug":"fda-new-cancer-indications-approvals-dec-2022","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-dec-2022\/","title":{"rendered":"FDA\u4e8e2022\u5e7412\u6708\u6279\u51c6\u4e866\u79cd\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>\u53bb\u5e7412\u6708\uff0cFDA\u6279\u51c6\u4e86\u516d\u79cd\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5176\u4e2d\u5305\u62ec\u66f4\u65b0\u4e86\u5361\u57f9\u4ed6\u6ee8\u7247\u5242\u7684\u9002\u5e94\u75c7\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u53e3\u670d\u5361\u57f9\u4ed6\u6ee8\u8bf4\u660e\u4e66\u66f4\u65b0\u3002<\/strong>\u6839\u636e\u80bf\u7624\u5353\u8d8a\u4e2d\u5fc3\uff08Oncology Center of Excellence\uff09\u7684\u9879\u76ee\u66f4\u65b0\uff08Project 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href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine\">\u83b7\u5f97\u4e86<\/a>\u836f\u54c1\u8bf4\u660e\u4e66\u7684\u66f4\u65b0\u3002\u5361\u57f9\u4ed6\u6ee8\u662f\u8be5\u8bd5\u70b9\u9879\u76ee\u4e2d\u7b2c\u4e00\u79cd\u83b7\u5f97\u836f\u54c1\u8bf4\u660e\u4e66\u66f4\u65b0\u7684\u836f\u7269\uff0c\u8be5\u8bd5\u70b9\u9879\u76ee\u5ba1\u6838\u4e0a\u5e02\u65f6\u95f4\u6bd4\u8f83\u957f\u7684\u5e38\u7528\u80bf\u7624\u836f\u7269\uff0c\u4ee5\u786e\u4fdd\u4fe1\u606f\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u548c\u79d1\u5b66\u524d\u6cbf\u6027\u3002\u8be5\u836f\u54c1\u8bf4\u660e\u4e66\u66f4\u65b0\u5305\u62ec\u7ed3\u76f4\u80a0\u764c\u3001\u665a\u671f\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u3001\u80f0\u817a\u764c\u4ee5\u53ca\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\u764c\u3001\u98df\u7ba1\u764c\u6216\u80c3\u98df\u7ba1\u7ed3\u5408\u90e8\u764c\u7684\u591a\u9879\u65b0\u7684\u548c\u7ecf\u8fc7\u4fee\u8ba2\u7684\u9002\u5e94\u8bc1\u3002\u65b0\u589e\u7684\u836f\u54c1\u8bf4\u660e\u4e66\u66f4\u65b0\u5305\u62ec\u591a\u79cd\u9002\u5e94\u8bc1\u7684\u5242\u91cf\u66f4\u65b0\uff0c\u5305\u62ec\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u53ef\u9009\u8f83\u4f4e\u8d77\u59cb\u5242\u91cf\u3002\u91cd\u5ea6\u80be\u529f\u80fd\u635f\u5bb3\u4e0d\u518d\u662f\u7981\u5fcc\u8bc1\uff0c\u5728\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879\u4e0b\u589e\u52a0\u4e86\u5173\u4e8e\u66b4\u9732\u4e8e\u78be\u788e\u836f\u7247\u7684\u65b0\u4fe1\u606f\u3002\u8fd8\u63d0\u4f9b\u4e86\u5173\u4e8e\u5361\u57f9\u4ed6\u6ee8\u4f7f\u7528\u548c\u4e8c\u6c22\u5627\u5576\u8131\u6c22\u9176\uff08DPD\uff09\u7f3a\u9677\u7684\u65b0\u589e\u4fe1\u606f\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u963f\u66ff\u5229\u73e0\u5355\u6297\u6cbb\u7597\u817a\u6ce1\u72b6\u8f6f\u7ec4\u7ec7\u8089\u7624\uff08ASPS\uff09\u3002<\/strong>\u5728\u4f18\u5148\u5ba1\u67e5\uff08PR\uff09\u548c\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08BTD\uff09\u4e4b\u540e\uff0c\u963f\u66ff\u5229\u73e0\u5355\u6297\uff08\u6cf0\u5723\u5947\u00ae\uff0c\u57fa\u56e0\u6cf0\u514b\/\u7f57\u6c0f\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-approval-atezolizumab-alveolar-soft-part-sarcoma\">\u6279\u51c6\u7528\u4e8e<\/a>\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027ASPS\u7684\u6210\u4eba\u548c\u22652\u5c81\u513f\u7ae5\u60a3\u8005\u3002\u8be5\u836f\u7269\u83b7\u5f97\u6279\u51c6\u662f\u57fa\u4e8e\u5f00\u653e\u6807\u7b7e\u3001\u5355\u81c22\u671f\u7814\u7a76<a href=\"https:\/\/www.cancer.gov\/news-events\/press-releases\/2022\/nci-trial-atezolizumab-approval-alveolar-soft-part-sarcoma\">ML39345<\/a>\uff08NCT03141684\uff09\u7684\u7ed3\u679c\u3002\u672c\u7814\u7a76\u7eb3\u5165\u4e8649\u4f8b\u22652\u5c81\u3001\u7ecf\u7ec4\u7ec7\u5b66\u6216\u7ec6\u80de\u5b66\u8bc1\u5b9e\u4e14\u4e0d\u80fd\u901a\u8fc7\u624b\u672f\u6cbb\u6108\u7684ASPS\u60a3\u8005\uff0c\u5e76\u4e14ECOG\u4f53\u80fd\u72b6\u6001\u8bc4\u5206\u22642\u5206\uff0c\u8bc4\u4f30\u4e86\u6297PD-L1\u6297\u4f53\u963f\u66ff\u5229\u73e0\u5355\u6297\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u4e3a\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u548c\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\u3002ORR\u4e3a24%\u300212\u4f8b\u6709\u6548\u60a3\u8005\u4e2d\uff0c\u6240\u6709\u60a3\u8005\u5747\u8fbe\u5230\u90e8\u5206\u7f13\u89e3\uff08PR\uff09\u3002\u5176\u4e2d2\/3\uff0867%\uff09\u60a3\u8005\u8fbe\u5230\u81f3\u5c116\u4e2a\u6708\u7684DoR\uff0c42%\u8fbe\u5230\u81f3\u5c1112\u4e2a\u6708\u7684DoR\u3002\u6210\u4eba\u60a3\u8005\u7684\u63a8\u8350\u5242\u91cf\u4e3a\u6bcf2\u5468840mg\u3001\u6bcf3\u54681200mg\u6216\u6bcf4\u54681680mg\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u3002\u7136\u800c\uff0c\u5bf9\u4e8e\u22652\u5c81\u7684\u513f\u7ae5\u60a3\u8005\uff0c\u5242\u91cf\u4e3a\u6bcf3\u546815mg\/kg\uff08\u6700\u9ad8\u4e3a1200mg\uff09\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Adagasib\u6cbb\u7597KRAS G12C\u7a81\u53d8\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u3002<\/strong>RAS GTP\u9176\u5bb6\u65cf\u6291\u5236\u5242adagasib\uff08Krazati\u00ae\uff0cMirati\u5236\u836f\uff09<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc\">\u83b7\u5f97\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u79cd\u5168\u8eab\u6027\u6cbb\u7597\u7684KRAS G12C\u7a81\u53d8\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC\u6210\u4eba\u60a3\u8005\u3002\u540c\u65f6\u6279\u51c6\u4e86\u4e24\u9879\u4f34\u968f\u8bca\u65ad\u8bd5\u9a8c\uff0c\u5373QIAGEN therascreen KRAS RGQ PCR\u8bd5\u5242\u76d2\uff08\u7ec4\u7ec7\uff09\u548cAgilent Resolution ctDx FIRST\u5206\u6790\u6d4b\u5b9a\uff08\u8840\u6d46\uff09\u3002<a href=\"https:\/\/www.nejm.org\/doi\/pdf\/10.1056\/nejmoa2204619\">KRYSTAL-1<\/a>\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u5355\u81c2\u3001\u5f00\u653e\u6807\u7b7e\u4e34\u5e8a\u7814\u7a76\uff0c\u7eb3\u5165\u4e86116\u4f8b\u7ecf\u8bc1\u5b9e\u6709KRAS G12C\u7a81\u53d8\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027NSCLC\u60a3\u8005\u3002\u5728\u51762\u671f\u6ce8\u518c\u7814\u7a76\u961f\u5217\u4e2d\uff0c\u7ecf\u8bc1\u5b9e\u7684ORR\u4e3a43%\uff08\u57fa\u7ebf\u65f6\u6709\u53ef\u6d4b\u91cf\u75c5\u53d8\u7684112\u4f8b\u60a3\u8005\u4e2d\u768448\u4f8b\uff1b95% CI\uff1a33.5\uff0c52.6\uff09\u3002\u4e2d\u4f4dDoR\u4e3a8.5\u4e2a\u6708\uff0895% CI\uff1a6.2\uff0c13.8\uff09\uff0c\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u4e3a6.5\u4e2a\u6708\uff0895% CI\uff1a4.7\uff0c8.4\uff09\u3002\u572833\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u4e14\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u8f6c\u79fb\u7a33\u5b9a\u7684\u60a3\u8005\u4e2d\uff0c\u8bc1\u5b9e\u7684\u9885\u5185ORR\u4e3a33.3%\u3002\u5171\u670952\u4f8b\uff0844.8%\uff09\u60a3\u8005\u53d1\u751f3\u7ea7\u53ca\u4ee5\u4e0aTRAEs\uff1b\u6700\u5e38\u89c1\u7684\u662f\u75b2\u52b3\u3001\u6076\u5fc3\u3001ALT\u6c34\u5e73\u5347\u9ad8\uff08\u5404\u53604.3%\uff09\u548cAST\u6c34\u5e73\u5347\u9ad8\uff083.4%\uff09\u3002\u672c\u7814\u7a76\u62a5\u544a\u4e862\u8d775\u7ea7\u81f4\u6b7b\u6027\u4e8b\u4ef6\uff08\u53d1\u751f\u4e8e1.7%\u7684\u60a3\u8005\uff09\u3002TRAE\u5bfc\u81f460\u4f8b\uff0851.7%\uff09\u60a3\u8005\u51cf\u91cf\uff0c71\u4f8b\uff0861.2%\uff09\u60a3\u8005\u505c\u836f\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u5361\u4ecb\u82d7\u65e0\u5e94\u7b54\u6027\u975e\u808c\u5c42\u6d78\u6da6\u6027\u8180\u80f1\u764c\uff08NMIBC\uff09\u7684\u9996\u4e2a\u57fa\u4e8e\u817a\u75c5\u6bd2\u8f7d\u4f53\u7684\u57fa\u56e0\u7597\u6cd5\u3002<\/strong>Nadofaragene firadenovec-vncg\uff08Adstiladrin\u00ae\uff0c\u8f89\u51cc\u5236\u836f\uff09<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin\">\u88ab\u6279\u51c6<\/a>\u7528\u4e8e\u9ad8\u5371\u5361\u4ecb\u82d7\uff08BCG\uff09\u65e0\u5e94\u7b54\u7684\u539f\u4f4d\u764c\uff08\u4f34\u6216\u4e0d\u4f34\u4e73\u5934\u72b6\u80bf\u7624\uff09NMIBC\u6210\u4eba\u60a3\u8005\u3002\u8fd9\u662f\u9996\u4e2a\u6279\u51c6\u7528\u4e8e\u8fd9\u4e00\u9002\u5e94\u8bc1\u7684\u57fa\u4e8e\u817a\u75c5\u6bd2\u8f7d\u4f53\u7684\u57fa\u56e0\u7597\u6cd5\u3002\u8fd9\u9879\u6279\u51c6\u662f\u57fa\u4e8e\u591a\u4e2d\u5fc3\u3001\u5355\u81c23\u671f\u4e34\u5e8a\u7814\u7a76<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(20)30540-4\/fulltext\">CS-003\uff08NCT02773849\uff09<\/a>\u7684\u7597\u6548\u6570\u636e\u3002\u5728\u7eb3\u5165\u7684157\u4f8b\u9ad8\u5371NMIBC\u60a3\u8005\u4e2d\uff0c98\u4f8b\u5361\u4ecb\u82d7\uff08BCG\uff09\u65e0\u5e94\u7b54\u7684\u539f\u4f4d\u764c\uff0c\u8bc4\u4f30\u5176\u5e94\u7b54\u60c5\u51b5\u3002\u4ee5\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\u548cDoR\u4e3a\u4e3b\u8981\u7597\u6548\u6307\u6807\u3002\u7814\u7a76\u8005\u8fdb\u884c\u4e86\u7ecf\u5c3f\u9053\u8180\u80f1\u80bf\u7624\u5207\u9664\u672f\uff08TURBT\uff09\u7684\u8180\u80f1\u955c\u68c0\u67e5\u4ee5\u53ca\u6d3b\u68c0\u548c\u5c3f\u7ec6\u80de\u5b66\u68c0\u67e5\uff0c\u4ee5\u8bc4\u4f30\u5e94\u7b54\u60c5\u51b5\u3002CR\u7387\u4e3a51%\uff0c\u4e2d\u4f4dDoR\u4e3a9.7\u4e2a\u6708\u3002\u5728\u6709\u5e94\u7b54\u7684\u60a3\u8005\u4e2d\uff0c\u8fd1\u4e00\u534a\uff0846%\uff09\u7684CR\u7ef4\u6301\u81f3\u5c1112\u4e2a\u6708\u3002\u60a3\u8005\u63a5\u53d7nadofaragene firadenovec-vncg 75 mL\u8180\u80f1\u704c\u6ce8\uff0c\u6bcf3\u4e2a\u67081\u6b21\uff0c\u6700\u957f12\u4e2a\u6708\u3002\u672a\u51fa\u73b0\u9ad8\u7ea7\u522b\u590d\u53d1\u7684\u60a3\u8005\u53ef\u4ee5\u7ee7\u7eed\u63a5\u53d7\u6bcf3\u4e2a\u67081\u6b21\u7684\u6cbb\u7597\u3002<br><br><\/li><li><strong>Olutasidenib\u6cbb\u7597\u590d\u53d1\u6216\u96be\u6cbb\u6027\uff08R\/R\uff09\u6025\u6027\u9ad3\u7cfb\u767d\u8840\u75c5\uff08AML\uff09\u3002<\/strong>Olutasidenib\uff08Rezlidhia\u2122\uff0cRigel\u5236\u836f\uff09\u5df2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-olutasidenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-idh1-mutation\">\u88ab\u6279\u51c6<\/a>\u7528\u4e8e\u6cbb\u7597\u6709\u6613\u611f\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1\uff08IDH1\uff09\u7a81\u53d8\u7684R\/R AML\u6210\u4eba\u60a3\u8005\uff0c\u8be5\u7a81\u53d8\u662f\u7531\u540c\u65f6\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u7684\u96c5\u57f9RealTime IDH1\u5206\u6790\u6d4b\u5b9a\u8fdb\u884c\u8bca\u65ad\u3002\u8fd9\u9879\u6279\u51c6\u662f\u57fa\u4e8e<a href=\"https:\/\/ash.confex.com\/ash\/2022\/webprogram\/Paper167330.html\">2102-HEM-101\u7814\u7a76<\/a>\uff08NCT02719574\uff09\u7684\u7ed3\u679c\uff0c\u8fd9\u662f\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u3001\u5355\u81c2\u30012\u671f\u591a\u4e2d\u5fc3\u6ce8\u518c\u7814\u7a76\uff0c\u7eb3\u5165\u4e86147\u4f8bIDH1\u7a81\u53d8\u786e\u8bca\u7684R\/R AML\u6210\u4eba\u60a3\u8005\u3002\u4e2d\u4f4d\u6cbb\u7597\u6301\u7eed\u65f6\u95f4\u4e3a4.7\u4e2a\u6708\uff0c11%\u7684\u60a3\u8005\u5728\u6cbb\u7597\u540e\u63a5\u53d7\u4e86\u540c\u79cd\u5f02\u4f53\u79fb\u690d\u3002\u4e3b\u8981\u7ec8\u70b9\u4e3aCR+\u4f34\u90e8\u5206\u8840\u6db2\u5b66\u6062\u590dCR\uff08CRh\uff09\u7387\u3002CR+CRh\u7387\u4e3a35%\uff0851\u4f8b\uff1b95% CI\uff1a27.0\uff0c43.0\uff09\uff0c\u4e2d\u4f4dCR\/CRh\u65f6\u95f4\u4e3a1.9\u4e2a\u6708\uff0895% CI\uff1a0.9\uff0c5.6\uff09\u3002ORR\u4e3a48%\uff08n=71\uff1b95% CI\uff1a40.0\uff0c56.7)\u3002\u4e4b\u524d\u63a5\u53d7\u8fc7\u7ef4\u5948\u514b\u62c9\u6cbb\u7597\u768412\u4f8b\u60a3\u8005\u7684\u7f13\u89e3\u7387\u76f8\u4f3c\u3002\u4e2d\u4f4dCR\/CRh\u6301\u7eed\u65f6\u95f4\u4e3a25.9\u4e2a\u6708\uff0895% CI\uff1a10.6\uff0cNE\uff09\u3002DOR\u4e2d\u4f4d\u6570\u4e3a11.7\u4e2a\u6708\uff0895% CI\uff1a6.9\uff0c25.9\uff09\u3002\u4e2d\u4f4dOS\u4e3a11.6\u4e2a\u6708\uff0895% CI\uff1a8.9\uff0c15.5\uff09\u3002\u226510%\u76843\/4\u7ea7TEAE\u4e3a\u53d1\u70ed\u6027\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u548c\u8d2b\u8840\uff08n=31\uff1b\u5404\u4e3a20%\uff09\uff0c\u8840\u5c0f\u677f\u51cf\u5c11\uff0825\u4f8b\uff1b16%\uff09\u548c\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff0820\u4f8b\uff1b13%\uff09\u3002FDA\u63a8\u8350\u5982\u679c\u6ca1\u6709\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u80fd\u8010\u53d7\u7684\u6bd2\u6027\uff0c\u60a3\u8005\u5e94\u8be5\u63a5\u53d7\u81f3\u5c116\u4e2a\u6708\u7684\u6cbb\u7597\uff0c\u4ee5\u8fbe\u5230\u4e34\u5e8a\u5e94\u7b54\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Mosunetuzumab-axgb<\/strong><strong>\u6cbb\u7597R\/R<\/strong><strong>\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624<\/strong><strong>\uff08FL<\/strong><strong>\uff09\u3002<\/strong>\u53cc\u7279\u5f02\u6027CD20\u4ecb\u5bfc\u7684CD3 T\u7ec6\u80de\u63a5\u5408\u5668mosunetuzumab-axgb\uff08Lunsumio\u2122\uff0c\u57fa\u56e0\u6cf0\u514b\/\u7f57\u6c0f\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-mosunetuzumab-axgb-relapsed-or-refractory-follicular-lymphoma\">\u52a0\u901f\u6279\u51c6<\/a>\u7528\u4e8e\u63a5\u53d7\u22652\u7ebf\u5168\u8eab\u6027\u6cbb\u7597\u540e\u7684R\/R FL\u6210\u4eba\u60a3\u8005\u3002\u5176\u7597\u6548\u5728\u5f00\u653e\u6807\u7b7e\u3001\u591a\u56fd\u3001\u591a\u961f\u52172\u671f\u7814\u7a76<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(22)00335-7\/fulltext\">GO29781<\/a>\uff08NCT02500407\uff09\u4e2d\u8fdb\u884c\u8bc4\u4f30\u3002\u6709\u6548\u4eba\u7fa4\u5305\u62ec90\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e24\u7ebf\u5168\u8eab\u6027\u6cbb\u7597\uff08\u5305\u62ec\u6297CD20\u5355\u514b\u9686\u6297\u4f53\u548c\u70f7\u5316\u5242\uff09\u7684R\/R FL\u60a3\u8005\u3002\u4e2d\u5fc3\u5b9e\u9a8c\u5ba4\u8bc4\u4f30\u7684ORR\u662f\u4e3b\u8981\u7684\u7597\u6548\u7ed3\u5c40\u6307\u6807\u3002ORR\u4e3a80%\uff0895% CI\uff1a70\uff0c88\uff09\uff0c60%\u7684\u60a3\u8005\u8fbe\u5230CR\u3002\u6709\u5e94\u7b54\u60a3\u8005\u7684\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a14.9\u4e2a\u6708\uff0c\u4f30\u8ba1\u4e2d\u4f4dDoR\u4e3a22.8\u4e2a\u6708\uff0895% CI\uff1b10\uff0c\u672a\u8fbe\u5230\uff09\u300212\u4e2a\u6708\u548c18\u4e2a\u6708\u7684\u4f30\u8ba1DoR\u5206\u522b\u4e3a62%\u548c57%\u3002\u5bf9\u4e8e\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u7684\u7ec6\u80de\u56e0\u5b50\u91ca\u653e\u7efc\u5408\u5f81\uff08CRS\uff09\uff0c\u5904\u65b9\u4fe1\u606f\u6709\u9ed1\u6846\u8b66\u544a\u3002\u8b66\u544a\u548c\u9884\u9632\u63aa\u65bd\u5305\u62ec\u795e\u7ecf\u6bd2\u6027\u3001\u611f\u67d3\u3001\u8840\u7ec6\u80de\u51cf\u5c11\u548c\u80bf\u7624\u53d1\u4f5c\u3002\u5728\u6309\u7167\u63a8\u8350\u5242\u91cf\u63a5\u53d7mosunetuzumab-axgb\u6cbb\u7597\u7684218\u4f8b\u60a3\u8005\u4e2d\uff0c39%\u53d1\u751f\u4e86CRS\uff0c39%\u53d1\u751f\u4e86\u795e\u7ecf\u6bd2\u6027\uff08\u5305\u62ec1%\u7684ICANS\uff09\uff0c17%\u53d1\u751f\u4e86\u4e25\u91cd\u611f\u67d3\uff0c4%\u53d1\u751f\u4e86\u71c3\u7624\u53cd\u5e94\u3002CRS\u76842\u7ea7\u53d1\u751f\u7387\u4e3a15%\uff0c3\u7ea7\u53d1\u751f\u7387\u4e3a2%\uff0c4\u7ea7\u53d1\u751f\u7387\u4e3a0.5%\u3002<strong><\/strong><\/li><\/ul>\n\n\n\n<hr 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