{"id":5563,"date":"2023-07-27T07:59:00","date_gmt":"2023-07-27T07:59:00","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5563"},"modified":"2023-11-07T14:13:40","modified_gmt":"2023-11-07T14:13:40","slug":"fda-new-cancer-indications-approvals-mar-apr-2023","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-mar-apr-2023\/","title":{"rendered":"FDA\u57282023\u5e743-4\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>\u7f8e\u56fdFDA\u4e8e2023\u5e743-4\u6708\u6279\u51c6\u4e866\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5728\u8fd9\u4e9b\u65b0\u6cbb\u7597\u5ba1\u6279\u4e2d\uff0c\u4e24\u4e2a\u662f\u9488\u5bf9\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u80bf\u7624\uff0c\u800c\u5176\u4ed6\u7528\u4e8e\u5c3f\u8def\u4e0a\u76ae\u764c\u548c\u9ed8\u514b\u5c14\u7ec6\u80de\u764c\uff0c\u4ee5\u53ca\u4e73\u817a\u764c\u7684\u6269\u5c55\u6279\u51c6\u3002\u6b64\u5916\uff0c\u4e00\u79cd\u836f\u7269\u88ab\u6279\u51c6\u7528\u4e8e\u513f\u7ae5\u4f4e\u7ea7\u522b\u80f6\u8d28\u7624\u3002<\/p>\n\n\n\n<ul 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href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy\">\u6269\u5c55\u6279\u51c6<\/a>\u7528\u4e8eHR\u9633\u6027\u3001HER2\u9634\u6027\u3001\u6dcb\u5df4\u7ed3\u9633\u6027\u5177\u6709\u9ad8\u5371\u590d\u53d1\u98ce\u9669\u7684\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u8f85\u52a9\u6cbb\u7597\u3002\u9ad8\u98ce\u9669\u60a3\u8005\u7684\u5b9a\u4e49\u5305\u62ec\uff1a\u6709\u22654\u4e2a\u75c5\u7406\u9633\u6027\u7684\u814b\u7a9d\u6dcb\u5df4\u7ed3\uff08pALN\uff09\u62161-3\u4e2apALN\uff0c\u4ee5\u53ca\u80bf\u7624\u5206\u7ea7\u4e3a3\u7ea7\u6216\u80bf\u7624\u5927\u5c0f\u226550mm\u7684\u60a3\u8005\u3002\u963f\u8d1d\u897f\u5229\u5148\u524d\u88ab\u6279\u51c6\u7528\u4e8eKi-67\u8bc4\u5206\u226520%\u7684\u9ad8\u5371\u60a3\u8005\u3002\u6b64\u6b21\u6279\u51c6\u53d6\u6d88\u4e86\u5bf9Ki-67\u7684\u68c0\u6d4b\u8981\u6c42\u3002\u5728\u968f\u673a\u3001\u53cc\u961f\u5217\u3001\u98ce\u9669\u5206\u5c42\u76843\u671f<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(22)00694-5\/fulltext\">monarchE\u7814\u7a76<\/a>\uff08NCT03155997\uff09\u4e2d\u8bc4\u4f30\u4e86\u7597\u6548\uff0c\u8be5\u7814\u7a76\u5165\u7ec4\u4e865637\u4f8bHR\u9633\u6027\u3001HER2\u9634\u6027\u3001\u6dcb\u5df4\u7ed3\u9633\u6027\u7684\u53ef\u5207\u9664\u7684\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005\uff0c\u5177\u6709\u9ad8\u98ce\u9669\u7684\u4e34\u5e8a\u548c\u75c5\u7406\u7279\u5f81\u3002\u6765\u81ea38\u4e2a\u56fd\u5bb663\u4e2a\u7814\u7a76\u4e2d\u5fc3\u7684\u60a3\u8005\u63a5\u53d7\u4e86\u6807\u51c6\u7684\u6700\u957f10\u5e74\u7684\u5185\u5206\u6ccc\u6cbb\u7597\u8054\u5408\u963f\u8d1d\u897f\u5229150mg\uff0c\u6bcf\u65e5\u53e3\u670d\u4e24\u6b21\uff0c\u4e3a\u671f2\u5e74\uff08n=2808\uff09\u6216\u5355\u72ec\u4f7f\u7528\u5185\u5206\u6ccc\u6cbb\u7597\uff08n=2829\uff09\u3002\u6839\u636e\u7814\u7a76\u8005\u7684\u62a5\u544a\uff0c\u5728\u63a5\u53d7\u963f\u8d1d\u897f\u5229\u7684\u60a3\u8005\u4e2d\uff0c\u4e3b\u8981\u7ec8\u70b9\u7684\u65e0\u4fb5\u88ad\u6027\u75be\u75c5\u751f\u5b58\u671f\uff08IDFS\uff09\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u6539\u5584\uff0c\u4e3b\u8981\u662f\u5728\u961f\u52171\u4e2d\u7b26\u5408\u9ad8\u5371\u6807\u51c6\u7684\u60a3\u8005\u4eba\u7fa4\u4e2d\uff1aHR=0.653\uff1b95%&nbsp;CI\uff1a0.567-0.753\u3002\u60a3\u8005\u961f\u52171\u7684\u963f\u8d1d\u897f\u5229\u7ec448\u4e2a\u6708\u65f6\u7684IDFS\u4e3a85.5%\uff0895% CI\uff1a83.8-87.0\uff09\uff0c\u800c\u5355\u7eaf\u5185\u5206\u6ccc\u6cbb\u7597\u7ec4\u7684IDFS\u4e3a78.6%\uff0895% CI\uff1a76.7-80.4\uff09\u3002\u867d\u7136\u603b\u751f\u5b58\u671f\uff08OS\uff09\u6570\u636e\u5c1a\u4e0d\u6210\u719f\uff0c\u4f46\u963f\u8d1d\u897f\u5229\u8054\u5408\u7ec4\u5728\u961f\u52172\uff081-3\u4e2a\u814b\u7a9d\u6dcb\u5df4\u7ed3\u9633\u6027\u548cKi-67\u81f3\u5c1120%\u4f5c\u4e3a\u989d\u5916\u98ce\u9669\u7279\u5f81\u7684\u60a3\u8005\uff09\u4e2d\u6b7b\u4ea1\u4eba\u6570\u591a\u4e8e\u5bf9\u7167\u7ec4\uff0c\u8fd9\u5bfc\u81f4FDA\u5c06\u9002\u5e94\u75c7\u9650\u5236\u5728\u961f\u52171\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Retifanlimab\u83b7\u6279\u6cbb\u7597\u665a\u671f\u9ed8\u514b\u5c14\u7ec6\u80de\u764c\uff08MCC\uff09\u3002<\/strong>Retifanlimab\uff08Zynyz\uff0cIncyte\u516c\u53f8\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel\">\u52a0\u901f\u6279\u51c6<\/a>\u7528\u4e8e\u8f6c\u79fb\u6216\u590d\u53d1\u7684\u5c40\u90e8\u665a\u671fMCC\u6210\u4eba\u60a3\u8005\u3002\u5728\u4e00\u98792\u671f\u3001\u5f00\u653e\u6807\u7b7e\u3001\u591a\u533a\u57df\u3001\u5355\u81c2\u7814\u7a76<a href=\"https:\/\/www.incytemi.com\/document\/Poster\/SITC%202021%20-%20POD1UM-201%20(Retifanlimab%20in%20MCC).pdf\">PODIUM-201<\/a>\uff08NCT03599713\uff09\u4e2d\uff0c\u5bf965\u4f8b\u672a\u7ecf\u5316\u7597\u7684\u8f6c\u79fb\u6027\u6216\u590d\u53d1\u6027\u5c40\u90e8\u665a\u671fMCC\u60a3\u8005\u8fdb\u884c\u4e86\u7597\u6548\u8bc4\u4f30\u3002\u6839\u636eRECIST v1.1\u6807\u51c6\uff0c\u7531\u72ec\u7acb\u4e2d\u592e\u8bc4\u5ba1\u59d4\u5458\u4f1a\u8bc4\u4f30\u7684\u5ba2\u89c2\u6709\u6548\u7387\uff08ORR\uff09\u548c\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u662f\u4e3b\u8981\u7597\u6548\u6307\u6807\u3002ORR\u4e3a52%\uff0895% CI\uff1a40-65\uff09\u300212\u4f8b\uff0818%\uff09\u60a3\u8005\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\uff0c22\u4f8b\uff0834%\uff09\u60a3\u8005\u8fbe\u5230\u90e8\u5206\u7f13\u89e3\uff08PR\uff09\u3002\u5728\u5e94\u7b54\u60a3\u8005\u4e2d\uff0c\u670926\u4f8b\uff0876%\uff09\u7684DOR\u22656\u4e2a\u6708\uff0c\u670921\u4f8b\uff0862%\uff09\u7684DOR\u226512\u4e2a\u6708\u3002\u5728105\u4f8b\u60a3\u8005\u4e2d\u8fdb\u884c\u5b89\u5168\u6027\u8bc4\u4f30\u3002\u6700\u5e38\u89c1\uff08\u226510%\uff09\u7684\u4e0d\u826f\u4e8b\u4ef6\uff08AEs\uff09\u662f\u75b2\u52b3\u3001\u808c\u8089\u9aa8\u9abc\u75bc\u75db\u3001\u7619\u75d2\u3001\u8179\u6cfb\u3001\u76ae\u75b9\u3001\u53d1\u70ed\u548c\u6076\u5fc3\u300222%\u7684\u60a3\u8005\u53d1\u751f\u4e25\u91cd\u7684AE\uff0c\u5305\u62ec\u75b2\u52b3\u3001\u5fc3\u5f8b\u5931\u5e38\u548c\u80ba\u708e\uff0c11%\u7684\u60a3\u8005\u56e0AE\u6c38\u4e45\u505c\u7528\u8be5\u7814\u7a76\u836f\u7269\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Enfortumab Vedotin\u4e0e\u5e15\u535a\u5229\u73e0\u5355\u6297\u8054\u5408\u6cbb\u7597\u7528\u4e8e\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08MUC\uff09<\/strong>\u3002Enfortumab vedotin\uff08Padcev\uff0c\u5b89\u65af\u6cf0\u6765\uff09\u8054\u5408\u5e15\u535a\u5229\u73e0\u5355\u6297\uff08\u53ef\u745e\u8fbe\uff0c\u9ed8\u6c99\u4e1c\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic\">\u52a0\u901f\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u4e0d\u9002\u5408\u987a\u94c2\u5316\u7597\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u60a3\u8005\u3002FDA\u6839\u636e\u591a\u961f\u5217\u7814\u7a76<a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.22.01643\">EV-103\/KEYNOTE-869<\/a>\uff08NCT03288545\uff09\u7684\u7ed3\u679c\u8bc4\u4f30\u4e86\u7597\u6548\uff0c\u5305\u62ecORR\u548cDOR\u3002\u8be5\u7814\u7a76\u5305\u62ec\u4e00\u4e2a\u5242\u91cf\u9012\u589e\u961f\u5217\u548c\u961f\u5217A\u7ec4\u6210\u7684\u5355\u81c2\u961f\u5217\uff0c\u4f7f\u7528enfortumab vedotin\u8054\u5408\u5e15\u535a\u5229\u73e0\u5355\u6cbb\u7597\u60a3\u8005\u3002\u800c<a href=\"https:\/\/oncologypro.esmo.org\/meeting-resources\/esmo-congress\/study-ev-103-cohort-k-antitumor-activity-of-enfortumab-vedotin-ev-monotherapy-or-in-combination-with-pembrolizumab-p-in-previously-untreated-c\">\u961f\u5217K<\/a>\u7684\u60a3\u8005\u88ab\u968f\u673a\u5206\u4e3a\u4e24\u7ec4\uff0c\u4e00\u7ec4\u63a5\u53d7\u8054\u5408\u6cbb\u7597\uff0c\u53e6\u4e00\u7ec4\u63a5\u53d7enfortumab vedotin\u5355\u72ec\u6cbb\u7597\u3002\u60a3\u8005\u65e2\u5f80\u6ca1\u6709\u63a5\u53d7\u8fc7\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u75be\u75c5\u7684\u5168\u8eab\u7cfb\u7edf\u6027\u6cbb\u7597\uff0c\u4e0d\u9002\u5408\u63a5\u53d7\u542b\u987a\u94c2\u7684\u5316\u7597\u3002\u91c7\u7528\u8054\u5408\u65b9\u6848\u6cbb\u7597\u7684\u60a3\u8005\uff08n=121\uff09\u6309\u7167RECIST v1.1\u6807\u51c6\u7684\u76f2\u6001\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u4f30\u4e0b\uff0c\u786e\u8ba4\u7684ORR\u4e3a68%\uff0895% CI\uff1a58.7-76.0\uff09\uff0c\u5176\u4e2d12%\u7684\u60a3\u8005\u8fbe\u5230CR\u3002\u5242\u91cf\u9012\u589e\/\u961f\u5217A\u7684\u4e2d\u4f4dDOR\u4e3a22.1\u4e2a\u6708\uff0c\u800c\u961f\u5217K\u5219\u672a\u8fbe\u5230\u3002\u5904\u65b9\u4fe1\u606f\u5305\u62ec\u5bf9\u4e25\u91cd\u76ae\u80a4\u53cd\u5e94\u4ee5\u53ca\u9ad8\u8840\u7cd6\u3001\u80ba\u708e\/\u95f4\u8d28\u6027\u80ba\u75be\u75c5\u3001\u5468\u56f4\u795e\u7ecf\u75c5\u53d8\u548c\u773c\u90e8\u75be\u75c5\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u8fbe\u62c9\u975e\u5c3c\u8054\u5408\u66f2\u7f8e\u66ff\u5c3c\u6cbb\u7597BRAFV600E\u7a81\u53d8\u7684\u513f\u7ae5\u4f4e\u7ea7\u522b\u795e\u7ecf\u80f6\u8d28\u7624\uff08LGG\uff09\u3002<\/strong><a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation\">\u8be5\u6279\u51c6<\/a>\u662f\u4f7f\u7528\u8fbe\u62c9\u975e\u5c3c\uff08\u6cf0\u83f2\u4e50\uff0c\u8bfa\u534e\uff09\u8054\u5408\u66f2\u7f8e\u66ff\u5c3c\uff08\u8fc8\u5409\u5b81\uff0c\u8bfa\u534e\uff09\u65b9\u6848\u6cbb\u7597\u5177\u6709BRAF&nbsp;V600E\u7a81\u53d8\u5e76\u9700\u8fdb\u884c\u7cfb\u7edf\u6027\u6cbb\u7597\u76841\u5c81\u53ca\u4ee5\u4e0a\u513f\u7ae5LGG\u60a3\u8005\u3002\u8fd9\u662fFDA\u7b2c\u4e00\u6b21\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\u6279\u51c6\u7cfb\u7edf\u6027\u6cbb\u7597\u3002\u6279\u51c6\u7684\u4f9d\u636e\u662f\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u76842\u671f\u7814\u7a76<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02684058\">CDRB436G2201<\/a>\uff08NCT02684058\uff09\uff0c\u4e00\u7ec4\u9700\u8981\u521d\u59cb\u5168\u8eab\u6cbb\u7597\u7684WHO 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href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-omidubicel-reduce-time-neutrophil-recovery-and-infection-patients-hematologic\">\u6279\u51c6<\/a>\u7528\u4e8e\u6210\u4eba\u548c\u513f\u7ae5\uff0812\u5c81\u53ca\u4ee5\u4e0a\uff09\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u80bf\u7624\u60a3\u8005\uff0c\u5728\u6e05\u9664\u9aa8\u9ad3\u540e\u8fdb\u884c\u8110\u8840\u79fb\u690d\uff0c\u4ee5\u51cf\u5c11\u4e2d\u6027\u7c92\u7ec6\u80de\u6062\u590d\u7684\u65f6\u95f4\u548c\u964d\u4f4e\u611f\u67d3\u7684\u53d1\u751f\u7387\u3002\u5728\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u30013\u671f\u7814\u7a76<a 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