{"id":5672,"date":"2023-11-07T15:31:00","date_gmt":"2023-11-07T15:31:00","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5672"},"modified":"2023-11-23T01:00:08","modified_gmt":"2023-11-23T01:00:08","slug":"fda-new-cancer-indications-approvals-aug-2023","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-aug-2023\/","title":{"rendered":"FDA\u57282023\u5e748\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>\u7f8e\u56fdFDA\u4e8e2023\u5e748\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5728\u8fd9\u4e9b\u65b0\u5ba1\u6279\u7684\u7597\u6cd5\u4e2d\uff0c\u4e24\u9879\u9488\u5bf9\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff0c\u5176\u4ed6\u7528\u4e8e\u80ba\u764c\u3001\u524d\u5217\u817a\u764c\u53ca\u7ed3\u80a0\u764c\u3002\u6b64\u5916\uff0c\u4e00\u79cd\u836f\u7269\u88ab\u6279\u51c6\u7528\u4e8e\u8461\u8404\u819c\u9ed1\u8272\u7d20\u7624\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><strong>\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\u6cbb\u7597\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\uff08mCRC\uff09\u3002<\/strong><\/strong>\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\uff08\u6717\u65af\u5f17\uff0c\u65e5\u672c\u5927\u9e4f\u5236\u836f\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-trifluridine-and-tipiracil-bevacizumab-previously-treated-metastatic-colorectal-cancer\">\u6279\u51c6<\/a>\u7528\u4e8e\u8054\u5408\u8d1d\u4f10\u73e0\u5355\u6297\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u6c1f\u5627\u5576\u7c7b\u3001\u5965\u6c99\u5229\u94c2\u548c\u4f0a\u7acb\u66ff\u5eb7\u4e3a\u57fa\u7840\u7684\u5316\u7597\uff0c\u4ee5\u53ca\u63a5\u53d7\u8fc7\u6297VEGF\u751f\u7269\u6cbb\u7597\u3001\u6297EGFR\u6cbb\u7597\uff08RAS\u91ce\u751f\u578b\uff09\u7684mCRC\u3002\u8fd9\u662f\u5bf92015\u5e74\u6279\u51c6\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\u5355\u836f\u6cbb\u7597\u8be5\u9002\u5e94\u75c7\u7684\u66f4\u65b0\u3002\u8be5\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u7684\u5168\u7403\u7814\u7a76<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2214963\">SUNLIGHT<\/a>\uff08NCT04737187\uff09\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6570\u636e\u3002\u8be5\u7814\u7a76\u5728492\u540d\u65e2\u5f80\u63a5\u53d7\u8fc7\u6700\u591a\u4e24\u79cd\u5316\u7597\u65b9\u6848\u4e14\u5bf9\u6700\u540e\u4e00\u79cd\u5316\u7597\u65b9\u6848\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u8010\u53d7\u7684mCRC\u60a3\u8005\u4e2d\uff0c\u5bf9\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\u8054\u5408\u4e0e\u4e0d\u8054\u5408\u8d1d\u4f10\u73e0\u5355\u6297\u8fdb\u884c\u4e86\u6bd4\u8f83\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7ed3\u5c40\u662f\u603b\u751f\u5b58\u671f\uff08OS\uff09\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3002\u4e0e\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\u5355\u836f\u6cbb\u7597\u7684\u60a3\u8005\u76f8\u6bd4\uff0c\u63a5\u53d7\u8d1d\u4f10\u73e0\u5355\u6297\u8054\u5408\u6cbb\u7597\u7684\u60a3\u8005OS\u6539\u5584\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\uff08HR=0.61\uff1b95%CI\uff1a0.49-0.77\uff1b\u5355\u4fa7<em>P<\/em>&lt;0.001\uff09\u3002\u8054\u5408\u6cbb\u7597\u7ec4\u7684\u4e2d\u4f4dOS\u4e3a10.8\u4e2a\u6708\uff0895%CI\uff1a9.4-11.8\uff09\uff0c\u66f2\u6c1f\u5c3f\u82f7\u66ff\u5339\u5627\u5576\u5355\u836f\u6cbb\u7597\u7ec4\u7684\u4e2d\u4f4dOS\u4e3a7.5\u4e2a\u6708\uff0895%CI\uff1a6.3-8.6\uff09\uff1b\u4e24\u7ec4\u7684\u4e2d\u4f4dPFS\u5206\u522b\u4e3a5.6\u4e2a\u6708\uff0895%CI\uff1a4.5-5.9\uff09\u548c2.4\u4e2a\u6708\uff0895%CI\uff1a2.1-3.2\uff09\uff0cHR=0.44\uff0895%CI\uff1a0.36-0.54\uff1b\u5355\u4fa7<em>P<\/em>&lt;0.001\uff09\u3002\u4e24\u7ec4\u4e2d\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\u662f\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u6076\u5fc3\u548c\u8d2b\u8840\uff0c\u6ca1\u6709\u4e0e\u6cbb\u7597\u76f8\u5173\u7684\u6b7b\u4ea1\u4e8b\u4ef6\u62a5\u544a\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><strong>\u666e\u62c9\u66ff\u5c3c\u7528\u4e8e\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u3002<\/strong><\/strong>\u53e3\u670d\u9009\u62e9\u6027RET\u6291\u5236\u5242\u666e\u62c9\u66ff\u5c3c\uff08\u666e\u5409\u534e\uff0c\u57fa\u56e0\u6cf0\u514b\/\u57fa\u77f3\uff09\u5df2\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions\">\u5e38\u89c4\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u4f7f\u7528FDA\u6279\u51c6\u7684\u68c0\u6d4b\u786e\u5b9a\u7684\u8f6c\u79fb\u6027RET\u878d\u5408\u9633\u6027NSCLC\u60a3\u8005\u30022020\u5e74\uff0c\u6839\u636e\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u591a\u961f\u5217\u7814\u7a76<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(21)00247-3\/fulltext\">ARROW<\/a>\uff08NCT03037385\uff09\u4e2d114\u4f8b\u5165\u7ec4\u60a3\u8005\u7684\u521d\u59cb\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u548c\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\uff0c\u666e\u62c9\u66ff\u5c3c\u83b7\u5f97\u4e86\u52a0\u901f\u6279\u51c6\u3002\u6b64\u6b21\u8f6c\u6362\u4e3a\u5e38\u89c4\u6279\u51c6\u7684\u4e3b\u8981\u4f9d\u636e\u662f25\u4e2a\u6708\u7684\u8fdb\u4e00\u6b65\u968f\u8bbf\u6570\u636e\u4ee5\u53ca123\u4f8b\u65b0\u589e\u60a3\u8005\u7684\u6570\u636e\u3002\u60a3\u8005\u6301\u7eed\u63a5\u53d7\u666e\u62c9\u66ff\u5c3c\u6cbb\u7597\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u53cd\u5e94\u3002\u6839\u636e\u76f2\u6cd5\u72ec\u7acb\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08BIRC\uff09\u8bc4\u4f30\uff0c107\u4f8b\u521d\u6cbb\u60a3\u8005\u7684ORR\u4e3a78%\uff0895%CI\uff1a68-85\uff09\uff0c\u4e2d\u4f4dDOR\u4e3a13.4\u4e2a\u6708\uff0895%CI\uff1a9.4-23.1\uff09\u3002\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u94c2\u7c7b\u5316\u7597\u7684130\u4f8b\u60a3\u8005\u4e2d\uff0cORR\u4e3a63%\uff0895%CI\uff1a54-71\uff09\uff0c\u4e2d\u4f4dDOR\u4e3a38.8\u4e2a\u6708\uff0895%CI\uff1a14.8-NE\uff09\u3002\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\uff08\u226525%\uff09\u4e3a\u808c\u8089\u9aa8\u9abc\u75bc\u75db\u3001\u4fbf\u79d8\u3001\u9ad8\u8840\u538b\u3001\u8179\u6cfb\u3001\u75b2\u52b3\u3001\u6c34\u80bf\u3001\u53d1\u70ed\u548c\u54b3\u55fd\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><strong>\u5c3c\u62c9\u5e15\u5229\u548c\u918b\u9178\u963f\u6bd4\u7279\u9f99\u6cbb\u7597BRCA\u7a81\u53d8\u7684\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u6027\u524d\u5217\u817a\u764c\uff08mCRPC\uff09\u3002<\/strong><\/strong>\u5c3c\u62c9\u5e15\u5229\uff08\u5219\u4e50\uff0cGSK\/\u518d\u9f0e\uff09\u548c\u918b\u9178\u963f\u6bd4\u7279\u9f99\uff08\u6cfd\u73c2\uff0c\u5f3a\u751f\uff09\u8054\u5408\u6cfc\u5c3c\u677e\u7684\u56fa\u5b9a\u5242\u91cf\u7ec4\u5408\u5df2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca-mutated-metastatic-castration\">\u83b7\u5f97\u6279\u51c6<\/a>\u7528\u4e8e\u7531FDA\u6279\u51c6\u7684\u68c0\u6d4b\u786e\u8ba4\u7684BRCA\u7a81\u53d8\u7684mCRPC\u60a3\u8005\u3002\u8be5\u6279\u51c6\u57fa\u4e8e\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u591a\u4e2d\u5fc3\u7814\u7a76<a href=\"https:\/\/www.annalsofoncology.org\/article\/S0923-7534(23)00757-3\/fulltext\">MAGNITUDE<\/a>\uff08NCT03748641\uff09\u961f\u52171\u7684\u7597\u6548\u6570\u636e\u3002423\u4f8b\u540c\u6e90\u91cd\u7ec4\u4fee\u590d\uff08HRR\uff09\u57fa\u56e0\u7a81\u53d8\u7684mCRPC\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u63a5\u53d7\u5c3c\u62c9\u5e15\u5229\u548c\u918b\u9178\u963f\u6bd4\u7279\u9f99\u53ca\u6cfc\u5c3c\u677e\u6cbb\u7597\u6216\u5b89\u6170\u5242\u548c\u918b\u9178\u963f\u6bd4\u7279\u9f99\u53ca\u6cfc\u5c3c\u677e\u6cbb\u7597\u3002\u5176\u4e2d\uff0c225\u4f8b\uff0853%\uff09\u60a3\u8005\u643a\u5e26BRCA\u57fa\u56e0\u7a81\u53d8\uff08BRCAm\uff09\u3002\u7814\u7a76\u7684\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u4e3aBICR\u6839\u636eRECIST\u00a0v1.1\u548cPCWG3\u6807\u51c6\u8bc4\u4f30\u7684\u5f71\u50cf\u5b66\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08rPFS\uff09\uff0cOS\u4e3a\u989d\u5916\u63a2\u7d22\u7ec8\u70b9\u3002\u5728BRCAm\u60a3\u8005\u4e9a\u7ec4\u4e2d\uff0c\u4e0e\u5b89\u6170\u5242\u7ec4\u76f8\u6bd4\uff0c\u5c3c\u62c9\u5e15\u5229\u7ec4\u7684rPFS\u6539\u5584\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\uff0c\u4e2d\u4f4drPFS\u4e3a16.6\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a10.9\u4e2a\u6708\uff08HR=0.53\uff1b95%CI\uff1a0.36-0.79\uff1b<em>P<\/em>=0.0014\uff09\u3002\u6b64\u5916\uff0c\u5c3c\u62c9\u5e15\u5229\u7ec4\u7684\u4e2d\u4f4dOS\u4e3a30.4\u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a28.6\u4e2a\u6708\uff08HR=0.79\uff1b95%CI\uff1a0.55-1.12\uff09\u3002\u5728\u961f\u52171\u4e2d\uff0c\u603b\u4f53\u6cbb\u7597\u610f\u5411\uff08ITT\uff09HRR\u4eba\u7fa4\u7684rPFS\u6539\u5584\u4e5f\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\uff08HR=0.73\uff1b95%CI\uff1a0.56-0.96\uff1b<em>P<\/em>\u00a0= 0.0217\uff09\u3002\u7136\u800c\uff0c\u8fdb\u4e00\u6b65\u7684\u5206\u6790\u663e\u793aITT HRR\u57fa\u56e0\u7a81\u53d8\u4eba\u7fa4\u7684\u6539\u5584\u4e3b\u8981\u5f52\u56e0\u4e8eBRCAm\u60a3\u8005\u4e9a\u7ec4\u3002\u5728\u961f\u52171\u4e2d\uff0c\u5c3c\u62c9\u5e15\u5229\u7ec427%\u7684\u60a3\u8005\u9700\u8981\u8f93\u8840\uff0c\u5176\u4e2d11%\u7684\u60a3\u8005\u9700\u8981\u591a\u6b21\u8f93\u8840\u3002\u5e38\u89c1\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u6307\u6807\u5f02\u5e38\u3001\u6076\u5fc3\u3001\u75b2\u52b3\u548c\u808c\u8089\u9aa8\u9abc\u75bc\u75db\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><strong>Melphalan\u6cbb\u7597\u8461\u8404\u819c\u9ed1\u8272\u7d20\u7624\u3002<\/strong><\/strong>\u542b\u6709melphalan\u7684HEPZATO KIT\uff08\u6ce8\u5c04\u7528melphalan\/\u809d\u8f93\u9001\u7cfb\u7edf\uff09\uff08HEPZATO\uff0cDelcath Systems\u516c\u53f8\uff09\u5df2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-melphalan-liver-directed-treatment-uveal-melanoma\">\u83b7\u5f97\u6279\u51c6<\/a>\u7528\u4e8e\u8461\u8404\u819c\u9ed1\u8272\u7d20\u7624\u809d\u810f\u5b9a\u5411\u6cbb\u7597\uff0c\u60a3\u8005\u9700\u5b58\u5728\u4fb5\u88ad\u809d\u810f\u672a\u53ca50%\u7684\u4e0d\u53ef\u5207\u9664\u7684\u809d\u8f6c\u79fb\uff0c\u4e14\u65e0\u809d\u5916\u75c5\u7076\u6216\u809d\u5916\u75c5\u7076\u4ec5\u5c40\u9650\u4e8e\u9aa8\u9abc\u3001\u6dcb\u5df4\u7ed3\u3001\u76ae\u4e0b\u7ec4\u7ec7\u6216\u80ba\u90e8\u7b49\u9002\u5408\u5207\u9664\u6216\u653e\u7597\u7684\u90e8\u4f4d\u3002\u8be5\u7ec4\u5408\u4ea7\u54c1\u901a\u8fc7\u65b0\u578b\u809d\u7ecf\u76ae\u704c\u6ce8\u8f93\u9001\u7cfb\u7edf\u5c06melphalan\u76f4\u63a5\u8f93\u9001\u5230\u809d\u810f\uff0c\u8fdb\u5165\u809d\u52a8\u8109\uff0c\u4ece\u800c\u5141\u8bb8\u9776\u7ec4\u7ec7\u4e2d\u66f4\u9ad8\u7684\u836f\u7269\u66b4\u9732\u3002\u8be5\u6279\u51c6\u7684\u4f9d\u636e\u662f\u5355\u81c2\u3001\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3\u7814\u7a76<a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2022.40.16_suppl.9510\">FOCUS<\/a>\uff08NCT02678572\uff09\u3002\u8be5\u7814\u7a76\u5305\u62ec91\u4f8b\u4f34\u4e0d\u53ef\u5207\u9664\u809d\u8f6c\u79fb\u7684\u8461\u8404\u819c\u9ed1\u8272\u7d20\u7624\u60a3\u8005\uff0c\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u6307\u6807\u4e3a\u72ec\u7acb\u4e2d\u592e\u5ba1\u67e5\u59d4\u5458\u4f1a\u6839\u636eRECIST 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class=\"wp-block-list\"><li><strong><strong>Talquetamab-tgvs\u7528\u4e8e\u590d\u53d1\/\u96be\u6cbb\u6027\uff08R\/R\uff09\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u3002<\/strong>Talquetamab-tgvs\u7528\u4e8e\u590d\u53d1\/\u96be\u6cbb\u6027\uff08R\/R\uff09\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u3002<\/strong>\u53cc\u7279\u5f02\u6027\u6297\u4f53talquetamab-tgvs\uff08Talvey\uff0c\u5f3a\u751f\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u56db\u7ebf\u6cbb\u7597\uff08\u5305\u62ec\u86cb\u767d\u9176\u4f53\u6291\u5236\u5242\u3001\u514d\u75ab\u8c03\u8282\u5242\u548c\u6297CD38\u5355\u514b\u9686\u6297\u4f53\uff09\u7684R\/R\u578b\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6210\u4eba\u60a3\u8005\u3002\u8fd9\u4e00\u6279\u51c6\u7684\u4f9d\u636e\u662f<a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2204591\">MMY1001\uff08MonumenTAL-1\uff09<\/a>\uff08NCT03399799\uff0cNCT4634552\uff09\u7814\u7a76\u4e2d\u7531\u72ec\u7acb\u5ba1\u67e5\u5458\u4f1a\u4f7f\u7528IMWG\u6807\u51c6\u8bc4\u4f30\u7684ORR\u548cDOR\u6570\u636e\u3002\u5728\u6bcf\u5468\u63a5\u53d70.4mg\/kg\u6cbb\u7597\u7684100\u4f8b\u60a3\u8005\u4e2d\uff0cORR\u4e3a73%\uff0895%\u00a0CI\uff1a63.2-81.4\uff09\uff0c\u4e2d\u4f4dDOR\u4e3a9.5\u4e2a\u6708\uff0895%CI\uff1a6.5-NE\uff09\u3002\u5728\u6bcf\u4e24\u5468\u63a5\u53d70.8mg\/kg\u6cbb\u7597\u768487\u4f8b\u60a3\u8005\u4e2d\uff0cORR\u4e3a73.6%\uff0895%CI\uff1a63-82.4\uff09\uff0c\u4e2d\u4f4dDOR\u4e0d\u53ef\u4f30\u8ba1\u3002\u63a8\u8350\u5242\u91cf\u4e3a\u6bcf\u54680.4mg\/kg\u6216\u6bcf\u4e24\u54680.8mg\/kg\u3002\u5927\u7ea685%\u7684\u5e94\u7b54\u60a3\u8005\u7f13\u89e3\u7ef4\u6301\u81f3\u5c119\u4e2a\u6708\u3002\u5728339\u4f8b\u60a3\u8005\u7684\u5b89\u5168\u6027\u4eba\u7fa4\u4e2d\uff0c\u53d1\u751f\u7387\u4e3a20%\u53ca\u4ee5\u4e0a\u7684\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u7ec6\u80de\u56e0\u5b50\u91ca\u653e\u7efc\u5408\u5f81\uff08CRS\uff09\u3001\u5473\u89c9\u969c\u788d\u3001\u6307\u7532\u75be\u75c5\u3001\u808c\u8089\u9aa8\u9abc\u75bc\u75db\u3001\u76ae\u80a4\u75c5\u3001\u76ae\u75b9\u3001\u75b2\u52b3\u3001\u4f53\u91cd\u51cf\u8f7b\u3001\u53e3\u5e72\u3001\u53d1\u70ed\u3001\u5e72\u71e5\u3001\u541e\u54bd\u56f0\u96be\u3001\u4e0a\u547c\u5438\u9053\u611f\u67d3\u548c\u8179\u6cfb\u3002Talquetamab\u7684\u5904\u65b9\u4fe1\u606f\u6709\u9ed1\u6846\u8b66\u544a\uff0c\u9488\u5bf9\u5371\u53ca\u751f\u547d\u6216\u81f4\u547d\u7684CRS\u548c\u795e\u7ecf\u7cfb\u7edf\u6bd2\u6027\uff0c\u5305\u62ec\u514d\u75ab\u6548\u5e94\u7ec6\u80de\u76f8\u5173\u795e\u7ecf\u6bd2\u6027\uff08ICANS\uff09\u3002Talquetamab\u53ea\u80fd\u901a\u8fc7\u79f0\u4e3aTecvayli-Talvey REMS\u7684\u98ce\u9669\u8bc4\u4f30\u548cREMS\u53d7\u9650\u8ba1\u5212\u83b7\u5f97\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><strong>Elranatamab-bcmm\u7528\u4e8eR\/R\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u3002<\/strong><\/strong>BCMA\/CD3\u53cc\u7279\u5f02\u6027\u6297\u4f53elranatamab-bcmm\uff08Elrexfio\uff0c\u8f89\u745e\uff09\u5df2\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u56db\u7ebf\u6cbb\u7597\uff08\u5305\u62ec\u86cb\u767d\u9176\u4f53\u6291\u5236\u5242\u3001\u514d\u75ab\u8c03\u8282\u5242\u548c\u6297CD38\u5355\u514b\u9686\u6297\u4f53\uff09\u7684R\/R\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6210\u4eba\u60a3\u8005\u3002\u8fd9\u4e00\u52a0\u901f\u6279\u51c6\u662f\u57fa\u4e8e\u5f00\u653e\u6807\u7b7e\u3001\u5355\u81c2\u3001\u591a\u4e2d\u5fc3\u7814\u7a76 <a href=\"https:\/\/www.nature.com\/articles\/s41591-023-02528-9\">MagnetisMM-3<\/a>\uff08NCT04649359\uff09\u7684ORR\u548cDOR\u6570\u636e\u3002\u8be5\u7814\u7a76\u4e2d\u7684\u60a3\u8005\u5bf9\u81f3\u5c11\u4e00\u79cd\u86cb\u767d\u9176\u4f53\u6291\u5236\u5242\u3001\u4e00\u79cd\u514d\u75ab\u8c03\u8282\u836f\u7269\u548c\u4e00\u79cd\u6297 CD38 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REMS\u7684\u98ce\u9669\u8bc4\u4f30\u548cREMS\u53d7\u9650\u8ba1\u5212\u83b7\u5f97\u3002<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fdFDA\u4e8e2023\u5e748\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5728\u8fd9\u4e9b\u65b0\u5ba1\u6279\u7684\u7597\u6cd5\u4e2d\uff0c\u4e24\u9879\u9488\u5bf9\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff0c\u5176\u4ed6\u7528\u4e8e\u80ba\u764c\u3001\u524d [&hellip;]<\/p>\n","protected":false},"author":805,"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-5672","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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content=\"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-aug-2023\/\" \/>\n<meta property=\"og:site_name\" content=\"ACE Oncology\" \/>\n<meta property=\"article:published_time\" content=\"2023-11-07T15:31:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-11-23T01:00:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/aceoncology.org\/wp-content\/uploads\/2022\/04\/Picture-Blog-Post-38_New-Drug-Approvals_Middle-Size.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"526\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Charlie Zheng\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ace_oncology\" \/>\n<meta name=\"twitter:site\" content=\"@ace_oncology\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" 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