{"id":5416,"date":"2023-05-25T08:17:42","date_gmt":"2023-05-25T08:17:42","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5416"},"modified":"2023-05-25T08:19:02","modified_gmt":"2023-05-25T08:19:02","slug":"fda-new-cancer-indications-approvals-jan-feb-2023","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-jan-feb-2023\/","title":{"rendered":"FDA\u57282023\u5e741-2\u6708\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>2023\u5e741-2\u6708\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5987\u79d1\u80bf\u7624\u6700\u591a\uff1a\u5176\u4e2d2\u9879\u6279\u51c6\u7528\u4e8e\u4e73\u817a\u764c\uff0c\u7b2c3\u9879\u6279\u51c6\u7528\u4e8e\u5b50\u5bab\u5185\u819c\u764c\u3002\u6b64\u5916\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\u5728NSCLC\u4e2d\u83b7\u5f97\u4e86\u65b0\u7684\u9002\u5e94\u8bc1\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>E<\/strong><strong>lacestrant\u7528\u4e8e<a><\/a><\/strong><strong>ER<\/strong><strong>\u9633\u6027<\/strong><strong>\u3001<\/strong><strong>HER<\/strong><strong>2\u9634\u6027<\/strong><strong>\u3001<\/strong><strong>ESR<\/strong><strong>1\u7a81\u53d8\u7684\u665a\u671f\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u3002<\/strong>Elacestrant\uff08Orserdu\uff0cStemline\u5236\u836f\uff09\u5df2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer\"><u>\u88ab\u6279\u51c6<\/u><\/a>\u7528\u4e8e\u63a5\u53d7\u81f3\u5c11\u4e00\u7ebf\u5185\u5206\u6ccc\u6cbb\u7597\u540e\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\u7684ER\u9633\u6027\u3001HER2\u9634\u6027\u3001ESR1\u7a81\u53d8\u7684\u7edd\u7ecf\u540e\u5973\u6027\u6216\u6210\u5e74\u7537\u6027\u665a\u671f\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u3002Guardant360 CDx\u68c0\u6d4b\u6cd5\u4e5f\u88ab\u6279\u51c6\u4f5c\u4e3a\u4f34\u968f\u8bca\u65ad\u8bbe\u5907\u3002\u6765\u81ea\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u30013\u671f<a href=\"https:\/\/ascopubs.org\/doi\/full\/10.1200\/JCO.22.00338\"><u>EMERALD\u7814\u7a76<\/u><\/a>\uff08NCT03778931\uff09\u7684\u7597\u6548\u6570\u636e\u652f\u6301\u8be5\u6279\u51c6\u3002\u60a3\u8005\uff08\u8fd1\u4e00\u534a\u6709ESR1\u7a81\u53d8\uff09\u88ab\u968f\u673a\u5206\u7ec4\uff0c\u5206\u522b\u63a5\u53d7\u6bcf\u65e51\u6b21\u53e3\u670delacestrant 345mg\u6216\u7814\u7a76\u8005\u9009\u62e9\u7684\u6807\u51c6\u5185\u5206\u6ccc\u5355\u836f\u6cbb\u7597\uff08\u5305\u62ec\u6c1f\u7ef4\u53f8\u7fa4\u6216\u82b3\u9999\u5316\u9176\u6291\u5236\u5242\uff09\u3002\u6240\u6709\u60a3\u8005\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u4f5c\u4e3a\u4e3b\u8981\u7ec8\u70b9\u5747\u5f97\u5230\u5ef6\u957f\uff08\u98ce\u9669\u6bd4[HR] 0.70\uff1b95%\u53ef\u4fe1\u533a\u95f4[CI]\uff1a0.55-0.88\uff1bP=0.002\uff09\u548cESR1\u7a81\u53d8\u60a3\u8005\uff08HR 0.55\uff1b95%CI\uff1a0.39-0.77\uff1bP=0.0005\uff09\u3002\u5728\u6709ESR1\u7a81\u53d8\u7684\u60a3\u8005\u4e2d\uff0celacestrant\u7ec4\u548c\u5185\u5206\u6ccc\u6cbb\u7597\u7ec4\u7684\u4e2d\u4f4dPFS\u5206\u522b\u4e3a3.8\u4e2a\u6708\uff0895%CI\uff1a2.2-7.3\uff09\u548c1.9\u4e2a\u6708\uff0895%CI\uff1a1.9-2.1\uff09\uff0c\u5177\u6709\u7edf\u8ba1\u5b66\u5dee\u5f02\uff08HR=0.55\uff1b95%CI\uff1a0.39-0.77\uff1bP=0.0005\uff09\u3002Elacestrant\u7ec43.4%\u7684\u60a3\u8005\u56e0\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08AE\uff09\u505c\u6b62\u6cbb\u7597\uff0c\u800c\u6807\u51c6\u6cbb\u7597\u7ec4\u4e3a0.9%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Sacituzumab Govitecan\u7528\u4e8eHR\u9633\u6027\u3001HER2\u9634\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u3002<\/strong>Sacituzumab govitecan\uff08Trodelvy\uff0c\u5409\u5229\u5fb7\uff09\u5df2<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer\"><u>\u88ab\u6279\u51c6<\/u><\/a>\u7528\u4e8e\u63a5\u53d7\u8fc7\u5185\u5206\u6ccc\u6cbb\u7597\u548c\u81f3\u5c11\u4e24\u79cd\u5176\u4ed6\u7cfb\u7edf\u6027\u6cbb\u7597\u7684\u8f6c\u79fb\u6027HR\u9633\u6027\u3001HER2\u9634\u6027\uff08IHC 0\u3001IHC 1+\u6216IHC 2+\/ISH-\uff09\u7684\u4e0d\u53ef\u5207\u9664\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u3002\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u30013\u671f<a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.2022.40.17_suppl.LBA1001\"><u>TROPiCS-02\u7814\u7a76<\/u><\/a>\uff08NCT03901339\uff09\u7684\u6570\u636e\u786e\u8ba4\u4e86\u5176\u7597\u6548\u3002\u7814\u7a76\u8005\u7eb3\u5165\u4e86543\u4f8b\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027HR\u9633\u6027\u3001HER2\u9634\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u5728\u63a5\u53d7CDK 4\/6\u6291\u5236\u5242\u3001\u5185\u5206\u6ccc\u6cbb\u7597\u548c\u7d2b\u6749\u7c7b\u836f\u7269\u6cbb\u7597\u540e\u53d1\u751f\u4e86\u75be\u75c5\u8fdb\u5c55\u3002\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c112\u79cd\u5316\u7597\u3002\u5c06\u60a3\u8005\u4ee51\u22361\u7684\u6bd4\u4f8b\u968f\u673a\u5206\u7ec4\uff0c\u5206\u522b\u63a5\u53d7sacituzumab govitecan\u6216\u533b\u751f\u9009\u62e9\u7684\u5355\u836f\u5316\u7597\u3002PFS\u662f\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u3002Sacituzumab govitecan\u7ec4\u7684\u4e2d\u4f4dPFS\u4e3a5.5\u4e2a\u6708\uff0895%CI\uff1a4.2-7.0\uff09\uff0c\u5316\u7597\u7ec4\u4e3a4\u4e2a\u6708\uff0895%CI\uff1a3.1-4.4\uff09\uff0c\u5177\u6709\u7edf\u8ba1\u5b66\u5dee\u5f02\uff08HR=0.661\uff1b95%CI\uff1a0.529-0.826\uff1bP=0.0003\uff09\u30026\u4e2a\u6708\u7684PFS\u7387\u5206\u522b\u4e3a46% vs 30%\uff0c12\u4e2a\u6708\u7684PFS\u7387\u5206\u522b\u4e3a21% vs 7%\u3002\u603b\u4f53\u800c\u8a00\uff0csacituzumab govitecan\u7ec474%\u7684\u60a3\u8005\u548c\u5316\u7597\u7ec460%\u7684\u60a3\u8005\u53d1\u751f\u4e86\u6cbb\u7597\u671f\u95f4\u53d1\u751f\u7684\u22653\u7ea7\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5176\u4e2d\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u6700\u5e38\u89c1\uff0851% vs 39%\uff09\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Dostarlimab\u6cbb\u7597\u9519\u914d\u4fee\u590d\u7f3a\u9677\u7684\u5b50\u5bab\u5185\u819c\u764c\u3002<\/strong>FDA<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-regular-approval-dostarlimab-gxly-dmmr-endometrial-cancer\"><u>\u6279\u51c6<\/u><\/a>dostarlimab\uff08Jemperli\uff0c\u845b\u5170\u7d20\u53f2\u514b\u516c\u53f8\uff09\u7528\u4e8e\u6cbb\u7597\u9519\u914d\u4fee\u590d\u7f3a\u9677\uff08dMMR\uff09\u590d\u53d1\u6027\u6216\u665a\u671f\u5b50\u5bab\u5185\u819c\u764c\uff0c\u5e76\u4e14\u9700\u8981\u901a\u8fc7FDA\u6279\u51c6\u7684\u68c0\u6d4b\u65b9\u6cd5\u8fdb\u884c\u786e\u8ba4\uff0c\u9002\u7528\u4e8e\u65e2\u5f80\u542b\u94c2\u5316\u7597\u65b9\u6848\u6cbb\u7597\u671f\u95f4\u6216\u4e4b\u540e\u53d1\u751f\u8fdb\u5c55\uff0c\u4e14\u4e0d\u9002\u5408\u63a5\u53d7\u6839\u6cbb\u6027\u624b\u672f\u6216\u653e\u7597\u7684\u60a3\u8005\u3002\u57282021\u5e74\uff0cdostarlimab\u83b7\u5f97\u4e86\u52a0\u901f\u5ba1\u6279\u3002\u9488\u5bf9\u5b9e\u4f53\u7624\u60a3\u8005\u7684\u591a\u961f\u5217\u3001\u591a\u4e2d\u5fc3\u5f00\u653e\u6807\u7b7e1\u671f<a href=\"https:\/\/jitc.bmj.com\/content\/10\/1\/e003777\"><u>GARNET\u7814\u7a76<\/u><\/a>\uff08NCT02715284\uff09\u786e\u8ba4\u4e86\u5176\u7597\u6548\u3002\u7597\u6548\u4eba\u7fa4\u5305\u62ec\u5728\u94c2\u7c7b\u65b9\u6848\u6cbb\u7597\u671f\u95f4\u6216\u6cbb\u7597\u540e\u53d1\u751f\u8fdb\u5c55\u7684141\u4f8bdMMR\u590d\u53d1\u6027\u6216\u665a\u671f\u5b50\u5bab\u5185\u819c\u764c\u60a3\u8005\u961f\u5217\u3002\u6839\u636eRECIST v1.1\u6807\u51c6\uff0c\u901a\u8fc7\u76f2\u6cd5\u3001\u72ec\u7acb\u3001\u4e2d\u5fc3\u5ba1\u6838\u8bc4\u4f30\u7684\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u548c\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u662f\u4e3b\u8981\u7597\u6548\u7ed3\u5c40\u8bc4\u4f30\u6307\u6807\u3002\u7ecf\u8bc1\u5b9e\u7684ORR\u4e3a45.4%\uff0895%CI\uff1a37.0-54.0\uff09\u3002\u5176\u4e2d\uff0c15.6%\u7684\u60a3\u8005\u8fbe\u5230\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\uff0c29.8%\u8fbe\u5230\u90e8\u5206\u7f13\u89e3\uff08PR\uff09\u3002\u4e2d\u4f4dDOR\u672a\u8fbe\u5230\uff0c\u4f4685.9%\u7684\u60a3\u8005\u75c5\u7a0b\u226512\u4e2a\u6708\uff0c54.7%\u7684\u60a3\u8005\u75c5\u7a0b\u226524\u4e2a\u6708\u300216.6%\u7684\u60a3\u8005\u53d1\u751f\u4e86\u22653\u7ea7\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff0c5.5%\u56e0\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u505c\u6b62\u7ee7\u7eed\u4f7f\u7528dostarlimab\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u56fe\u5361\u66ff\u5c3c\u8054\u5408\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u665a\u671f\u7ed3\u76f4\u80a0\u764c\u3002<\/strong>\u56fe\u5361\u66ff\u5c3c\uff08Tukysa\uff0cSeagen\u5236\u836f\uff09\u8054\u5408\u66f2\u59a5\u73e0\u5355\u6297\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-tucatinib-trastuzumab-colorectal-cancer\"><u>\u52a0\u901f\u6279\u51c6<\/u><\/a>\u7528\u4e8eRAS\u91ce\u751f\u578bHER2\u9633\u6027\u3001\u5728\u6c1f\u5627\u5576\u3001\u5965\u6c99\u5229\u94c2\u548c\u4f0a\u7acb\u66ff\u5eb7\u4e3a\u57fa\u7840\u7684\u5316\u7597\u540e\u8fdb\u5c55\u7684\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u3002\u8be5\u836f\u7269\u7684\u6279\u51c6\u662f\u57fa\u4e8e\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc32\u671f<a href=\"https:\/\/www.annalsofoncology.org\/article\/S0923-7534(22)01130-9\/fulltext\"><u>MOUNTAINEER\u7814\u7a76<\/u><\/a>\uff08NCT03043313\uff09\u7684\u7597\u6548\u6570\u636e\u3002\u7eb3\u5165\u7814\u7a76\u7684\u60a3\u8005\u4e3aHER2\u9633\u6027\u3001RAS\u91ce\u751f\u578b\u3001\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\uff0c\u65e2\u5f80\u63a5\u53d7\u8fc7\u6c1f\u5627\u5576\u3001\u5965\u6c99\u5229\u94c2\u3001\u4f0a\u7acb\u66ff\u5eb7\u548c\u6297\u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50\uff08VEGF\uff09\u6cbb\u7597\u3002\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u662fORR\u548cDOR\uff0c\u91c7\u7528RECIST v1.1\u6807\u51c6\uff0c\u901a\u8fc7\u76f2\u6cd5\u72ec\u7acb\u96c6\u4e2d\u5ba1\u6838\u8fdb\u884c\u8bc4\u4f30\u3002\u7ecf\u8bc1\u5b9e\u7684ORR\u4e3a38.1%\uff0895%CI\uff1a27.7-49.3\uff09\u3002\u4e2d\u4f4dDOR\u4e3a12.4\u4e2a\u6708\uff0895%CI\uff1a8.5-20.5\uff09\u3002\u6700\u5e38\u89c1\u7684\u22653\u7ea7AE\u662f\u9ad8\u8840\u538b\uff087.0%\uff09\uff0c5.8%\u7684\u60a3\u8005\u56e0AE\u505c\u836f\u3002\u63a8\u8350\u56fe\u5361\u66ff\u5c3c\u7684\u5242\u91cf\u4e3a\u6bcf\u65e52\u6b21\uff0c\u6bcf\u6b21300mg\u53e3\u670d\u8054\u5408\u66f2\u59a5\u73e0\u5355\u6297\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>\u5e15\u535a\u5229\u73e0\u5355\u6297\u7528\u4e8e\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u8f85\u52a9\u6cbb\u7597\u3002<\/strong>\u6839\u636e3\u671f<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(22)00518-6\/fulltext\"><u>KEYNOTE-091\u7814\u7a76<\/u><\/a>\uff08NCT02504372\uff09\u7684\u7597\u6548\u6570\u636e\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\uff08\u53ef\u745e\u8fbe\uff0c\u9ed8\u6c99\u4e1c\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-pembrolizumab-adjuvant-treatment-non-small-cell-lung-cancer\"><u>\u6279\u51c6<\/u><\/a>\u7528\u4e8eIb\u671f\uff08T2a\u22654cm\uff09\u3001II\u671f\u6216IIIa\u671fNSCLC\u5207\u9664\u672f\u548c\u94c2\u7c7b\u5316\u7597\u540e\u7684\u8f85\u52a9\u6cbb\u7597\u3002KEYNOTE-091\u662f\u4e00\u9879\u9488\u5bf9\u672a\u63a5\u53d7\u8fc7\u65b0\u8f85\u52a9\u653e\u7597\u6216\u5316\u7597\u7684\u60a3\u8005\u7684\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u4e09\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7814\u7a76\u3002\u60a3\u8005\u88ab\u968f\u673a\u5206\u7ec4\uff0c\u5206\u522b\u63a5\u53d7\u6bcf3\u54681\u6b21200mg\u5e15\u535a\u5229\u73e0\u5355\u6297\u6216\u5b89\u6170\u5242\u9759\u8109\u7ed9\u836f\uff0c\u6700\u957f1\u5e74\u3002\u5728\u968f\u673a\u5206\u7ec4\u7684\u8fd11200\u4f8b\u60a3\u8005\uff08n=1177\uff09\u4e2d\uff0c86%\u7684\u60a3\u8005\uff08n=1,010\uff09\u5728\u5b8c\u5168\u5207\u9664\u672f\u540e\u63a5\u53d7\u4e86\u94c2\u7c7b\u8f85\u52a9\u5316\u7597\u3002\u5728\u603b\u4f53\u4eba\u7fa4\u548cPD-L1\u80bf\u7624\u6bd4\u4f8b\u8bc4\u5206\uff08TPS\uff09\u226550%\u7684\u60a3\u8005\u4e2d\uff0c\u7814\u7a76\u8005\u5224\u5b9a\u7684\u65e0\u75c5\u751f\u5b58\u671f\uff08DFS\uff09\u662f\u53cc\u91cd\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u3002\u6574\u4e2a\u4eba\u7fa4\u7684DFS\u6709\u7edf\u8ba1\u5b66\u663e\u8457\u6539\u5584\uff08HR=0.76\uff1b95%CI\uff1a0.63~0.91\uff1bP=0.0014\uff09\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\u7ec4\u7684\u4e2d\u4f4dDFS\u4e3a53.6\u4e2a\u6708\uff0895%CI\uff1a39.2-\u672a\u8fbe\u5230\uff09\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a42.0\u4e2a\u6708\uff0895%CI\uff1a31.3-\u672a\u8fbe\u5230\uff09\u3002\u5bf9\u672a\u63a5\u53d7\u8f85\u52a9\u5316\u7597\u7684\u60a3\u8005\u4e9a\u7ec4\uff08n=167\uff09\u8fdb\u884c\u63a2\u7d22\u6027\u5206\u6790\uff0cDFS\u98ce\u9669\u6bd4\u4e3a1.25\uff0895%CI\uff1a0.76-2.05\uff09\u3002\u5728\u63a5\u53d7\u8f85\u52a9\u5316\u7597\u7684\u60a3\u8005\u4e2d\uff08HR=0.73\uff1b95%CI\uff1a0.60-0.89\uff09\uff0c\u5e15\u535a\u5229\u73e0\u5355\u6297\u7ec4\u548c\u5b89\u6170\u5242\u7ec4\u7684\u4e2d\u4f4dDFS\u5206\u522b\u4e3a58.7\u4e2a\u6708\uff0895%CI\uff1a39.2-\u672a\u8fbe\u5230\uff09\u548c34.9\u4e2a\u6708\uff0895%CI\uff1a28.6-\u672a\u8fbe\u5230\uff09\u3002\u9664\u4e86\u7532\u72b6\u817a\u529f\u80fd\u51cf\u9000(22%)\u3001\u7532\u72b6\u817a\u529f\u80fd\u4ea2\u8fdb(11%)\u548c\u80ba\u708e(7%)\u4e4b\u5916\uff0c\u4e0d\u826f\u4e8b\u4ef6\u4e0e\u63a5\u53d7\u5e15\u535a\u5229\u73e0\u5355\u6297\u5355\u836f\u6cbb\u7597\u7684NSCLC\u60a3\u8005\u7684\u4e0d\u826f\u4e8b\u4ef6\u4e00\u822c\u76f8\u4f3c\u3002\u53d1\u751f2\u4f8b\u81f4\u6b7b\u6027\u5fc3\u808c\u708e\u4e0d\u826f\u53cd\u5e94\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u6cfd\u5e03\u66ff\u5c3c\u6cbb\u7597\u6162\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\uff08CLL\uff09\u3002<\/strong>\u6cfd\u5e03\u66ff\u5c3c\uff08\u767e\u60a6\u6cfd\uff0c\u767e\u6d4e\u795e\u5dde\uff09<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-zanubrutinib-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma\"><u>\u83b7\u6279<\/u><\/a>\u7528\u4e8e\u6cbb\u7597CLL\u6216\u5c0f\u6dcb\u5df4\u7ec6\u80de\u6dcb\u5df4\u7624\uff08SLL\uff09\u3002\u5f00\u653e\u6807\u7b7e3\u671f<a href=\"https:\/\/www.thelancet.com\/journals\/lanonc\/article\/PIIS1470-2045(22)00293-5\/fulltext\"><u>SEQUOIA\u7814\u7a76<\/u><\/a>\uff08NCT03336333\uff09\u7684\u7597\u6548\u6570\u636e\u786e\u5b9a\u4e86\u5176\u5728\u4e00\u7ebf\u6cbb\u7597\u4e2d\u7684\u5e94\u7528\u3002\u65e0del\uff0817\uff09\uff08p13.1\uff09\u7684\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u5230\u6cfd\u5e03\u66ff\u5c3c\u7ec4\uff08A\u7ec4\uff09\u6216\u82ef\u8fbe\u83ab\u53f8\u6c40-\u5229\u59a5\u6614\u5355\u6297\u7ec4\uff08B\u7ec4\uff09\u3002\u800c\u5177\u6709del\uff0817\uff09\uff08p1.1\uff09\u7684\u60a3\u8005\u88ab\u7eb3\u5165C\u7ec4\uff0c\u63a5\u53d7\u6cfd\u5e03\u66ff\u5c3c\u6cbb\u7597\u3002\u4e3b\u8981\u7ec8\u70b9\u662fA\u7ec4\u548cB\u7ec4\u6839\u636e\u72ec\u7acb\u8bc4\u4f30\u5224\u5b9a\u7684PFS\u3002\u4e2d\u4f4d\u968f\u8bbf25.0\u4e2a\u6708\u65f6\uff0c\u4e24\u7ec4\u5747\u672a\u8fbe\u5230\u4e2d\u4f4dPFS\u3002A\u7ec4PFS\u663e\u8457\u4f18\u4e8eB\u7ec4\uff08HR=0.42\uff1b95%CI\uff1a0.28-0.63\uff1bP&lt;0.0001\uff09\u3002\u5728\u6279\u51c6\u6cfd\u5e03\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6027CLL\u6216SLL\u65f6\uff0cFDA\u540c\u65f6\u53c2\u8003\u4e863\u671f<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2211582\"><u>ALPINE\u7814\u7a76<\/u><\/a>\uff08NCT03734016\uff09\u7684\u7597\u6548\u6570\u636e\uff0c\u8be5\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ec8\u70b9\u662f\u603b\u4f53\u7f13\u89e3\uff0cPFS\u662f\u5173\u952e\u7684\u6b21\u8981\u7ec8\u70b9\u3002\u4e2d\u4f4d\u968f\u8bbf29.6\u4e2a\u6708\u65f6\uff0c\u6cfd\u5e03\u66ff\u5c3c\u5728PFS\u65b9\u9762\u4f18\u4e8e\u4f0a\u5e03\u66ff\u5c3c\uff08\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u7684HR=0.65\uff1b95%CI\uff1a0.49-0.86\uff1bP=0.002\uff09\u300224\u4e2a\u6708\u65f6\uff0c\u6cfd\u5e03\u66ff\u5c3c\u7ec4\u548c\u4f0a\u5e03\u66ff\u5c3c\u7ec4\u7684PFS\u7387\u5206\u522b\u4e3a78.4%\u548c65.9%\u3002\u5728\u670917p\u7f3a\u5931\u3001TP53\u7a81\u53d8\u6216\u8fd9\u4e24\u79cd\u60c5\u51b5\u7684\u60a3\u8005\u4e2d\uff0c\u63a5\u53d7\u6cfd\u5e03\u66ff\u5c3c\u6cbb\u7597\u7684\u60a3\u8005\u7684PFS\u8d85\u8fc7\u4f0a\u5e03\u66ff\u5c3c\u7ec4\uff08\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u7684HR=0.53\uff1b95%CI\uff1a0.31-0.88\uff09\u3002FDA\u6307\u51fa\uff0c\u5728\u5404\u7814\u7a76\u4e2d\uff0c\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u662f\u6700\u5e38\u89c1\u7684AE\uff0842%\uff09\uff0c\u5176\u6b21\u662f\u4e0a\u547c\u5438\u9053\u611f\u67d3\uff0839%\uff09\u548c\u8840\u5c0f\u677f\u8ba1\u6570\u51cf\u5c11\uff0834%\uff09\u300213%\u7684\u60a3\u8005\u53d1\u751f\u7b2c\u4e8c\u79cd\u6076\u6027\u80bf\u7624\uff0c3.7%\u7684\u60a3\u8005\u62a5\u544a\u623f\u98a4\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Pirtobrutinib\u6cbb\u7597\u5957\u7ec6\u80de\u6dcb\u5df4\u7624\uff08MCL\uff09\u3002<\/strong>Pirtobrutinib\uff08Jaypirca\uff0c\u793c\u6765\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma\"><u>\u52a0\u901f\u6279\u51c6<\/u><\/a>\u7528\u4e8e\u63a5\u53d7\u81f3\u5c11\u4e24\u7ebf\u5168\u8eab\u6027\u6cbb\u7597\uff08\u5305\u62ecBTK\u6291\u5236\u5242\uff09\u540e\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027MCL\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e1\/2\u671f<a href=\"https:\/\/ash.confex.com\/ash\/2022\/webprogram\/Paper159425.html\"><u>BRUIN\u7814\u7a76<\/u><\/a>\uff08NCT03740529\uff09\u7684\u7597\u6548\u6570\u636e\uff0c\u8fd9\u662f\u4e00\u9879\u5173\u4e8epirtobrutinib\u5355\u836f\u6cbb\u7597\u7684\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3\u3001\u5355\u81c2\u7814\u7a76\u3002\u672c\u7814\u7a76\u7eb3\u5165\u4e86120\u4f8b\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u79cdBTK\u6291\u5236\u5242\u6cbb\u7597\u7684MCL\u60a3\u8005\uff0c83%\u7684\u60a3\u8005\u56e0\u96be\u6cbb\u6027\u6216\u8fdb\u5c55\u6027\u75be\u75c5\u800c\u505c\u7528\u6700\u540e\u4e00\u79cdBTK\u6291\u5236\u5242\u3002\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u662fORR\u548cDOR\uff0c\u7531\u72ec\u7acb\u5ba1\u67e5\u59d4\u5458\u4f1a\u4f7f\u7528Lugano\u6807\u51c6\u786e\u5b9a\u3002ORR\u4e3a50%\uff0895%CI\uff1a41-59\uff09\uff0c\u5b8c\u5168\u7f13\u89e3\u7387\u4e3a13%\u3002\u4f30\u8ba1\u7684\u4e2d\u4f4dDOR\u4e3a8.3\u4e2a\u6708\uff0895%CI\uff1a5.7-\u4e0d\u53ef\u4f30\u8ba1\uff09\uff0c6\u4e2a\u6708\u65f6\u7684DOR\u7387\u9884\u4f30\u4e3a65.3%\uff0895%CI\uff1a49.8-77.1\uff09\u3002\u81f3\u5c1115%\u7684\u60a3\u8005\u7ecf\u5386\u4e86\u4ee5\u4e0b\u4e0d\u826f\u4e8b\u4ef6\uff1a\u75b2\u52b3\u3001\u808c\u8089\u9aa8\u9abc\u75bc\u75db\u3001\u8179\u6cfb\u3001\u6c34\u80bf\u3001\u547c\u5438\u56f0\u96be\u3001\u80ba\u708e\u548c\u7600\u4f24\u3002\u63a8\u8350\u7684pirtobrutinib\u5242\u91cf\u4e3a\u6bcf\u65e51\u6b21\uff0c\u6bcf\u6b21200mg\u53e3\u670d\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u53ef\u8010\u53d7\u7684\u6bd2\u6027\u3002\u5904\u65b9\u4fe1\u606f\u4e2d\u5305\u542b\u5bf9\u611f\u67d3\u3001\u51fa\u8840\u3001\u8840\u7ec6\u80de\u51cf\u5c11\u3001\u623f\u98a4\u548c\u623f\u6251\u4ee5\u53ca\u7b2c\u4e8c\u539f\u53d1\u6076\u6027\u80bf\u7624\u7684\u8b66\u544a\u548c\u9884\u9632\u3002<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>2023\u5e741-2\u6708\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5987\u79d1\u80bf\u7624\u6700\u591a\uff1a\u5176\u4e2d2\u9879\u6279\u51c6\u7528\u4e8e\u4e73\u817a\u764c\uff0c\u7b2c3\u9879\u6279\u51c6\u7528\u4e8e\u5b50\u5bab [&hellip;]<\/p>\n","protected":false},"author":719,"featured_media":4328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[42],"tags":[],"class_list":["post-5416","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-42"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA\u57282023\u5e741-2\u6708\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5 - ACE Oncology<\/title>\n<meta name=\"description\" content=\"\u7f8e\u56fdFDA\u57282023\u5e741-2\u6708\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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