{"id":9583,"date":"2024-01-25T22:06:33","date_gmt":"2024-01-26T03:06:33","guid":{"rendered":"https:\/\/newswz.com\/?p=9583"},"modified":"2024-01-25T22:06:35","modified_gmt":"2024-01-26T03:06:35","slug":"%e5%a4%a9%e4%bb%b7%e7%a5%9e%e8%8d%afcar-t%e5%8f%af%e8%83%bd%e8%87%b4%e7%99%8c%ef%bc%8cfda%e7%b4%a7%e6%80%a5%e8%ad%a6%e5%91%8a","status":"publish","type":"post","link":"https:\/\/newswz.com\/?p=9583","title":{"rendered":"\u5929\u4ef7\u795e\u836fCAR-T\u53ef\u80fd\u81f4\u764c\uff0cFDA\u7d27\u6025\u8b66\u544a"},"content":{"rendered":"\n<p>\u6587\u7ae0\u6765\u6e90:\u00a0 \u500d\u53ef\u4eb2 \u2013 \u65b0\u95fb\u53d6\u81ea\u5404\u5927\u65b0\u95fb\u5a92\u4f53\uff0c\u65b0\u95fb\u5185\u5bb9\u5e76\u4e0d\u4ee3\u8868\u672c\u7f51\u7acb\u573a\uff01<\/p>\n\n\n\n<p>\u3000<strong>\u6838\u5fc3\u63d0\u8981\uff1a<\/strong><\/p>\n\n\n\n<p>\u3000\u30001. \u56e0120\u4e07\u5143\u4e00\u9488\u800c\u706b\u7206\u7684\u5929\u4ef7\u6297\u764c\u795e\u836fCAR-T\u7ec6\u80de\u514d\u75ab\u7597\u6cd5\uff0c\u6b63\u9762\u4e34\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u7d27\u6025\u8b66\u544a\uff1a\u60a3\u8005\u63a5\u53d7\u6cbb\u7597\u540e\u53ef\u80fd\u51fa\u73b0\u7b2c\u4e8c\u6076\u6027\u80bf\u7624\u3002FDA\u5df2\u6536\u523025\u4f8b\u6cbb\u7597\u540e\u51fa\u73b0T\u7ec6\u80de\u6076\u6027\u80bf\u7624\u7684\u62a5\u544a\uff0c\u5176\u4e2d\u4e25\u91cd\u60a3\u8005\u5df2\u7ecf\u6b7b\u4ea1\u3002\u8fd9\u6b3e\u7597\u6cd5\u4e0d\u4ec5\u5177\u6709\u4ef7\u683c\u9ad8\u6602\u3001\u7ed9\u836f\u7b49\u5f85\u65f6\u95f4\u957f\u3001\u6cbb\u7597\u540e\u590d\u53d1\u5feb\u7b49\u7f3a\u70b9\uff0c\u8fd8\u9677\u5165\u4e86\u5f15\u53d1\u7b2c\u4e8c\u79cd\u764c\u75c7\u7684\u5b89\u5168\u6027\u98ce\u6ce2\u3002<\/p>\n\n\n\n<p>\u3000\u30002. FDA\u5df2\u8981\u6c426\u6b3eCAR-T\u4ea7\u54c1\u6dfb\u52a0\u9ed1\u6846\u8b66\u544a\uff0c\u5e76\u6307\u51fa\u4f7f\u7528\u9776\u5411BCMA\u6216CD19\u7684CAR-T\u6cbb\u7597\u53ef\u80fd\u5bfc\u81f4T\u7ec6\u80de\u6076\u6027\u80bf\u7624\uff0c\u5176\u4e2d\u5305\u62ec\u56fd\u5185\u4f20\u5947\u751f\u7269\u5236\u836f\u7684\u897f\u8fbe\u57fa\u5965\u4ed1\u8d5b\u3002<\/p>\n\n\n\n<p>\u3000\u30003. \u56fd\u5185\u5df2\u83b7\u6279\u4e0a\u5e02\u7684\u56db\u6b3eCAR-T\u7597\u6cd5\u5206\u522b\u4e3a\u590d\u661f\u51ef\u7279\u7684\u963f\u57fa\u4ed1\u8d5b\u3001\u836f\u660e\u5de8\u8bfa\u7684\u745e\u57fa\u5965\u4ed1\u8d5b\u3001\u9a6f\u9e7f\u751f\u7269\u7684\u4f0a\u57fa\u5965\u4ed1\u8d5b\uff0c\u4ee5\u53ca\u5408\u6e90\u751f\u7269\u7684\u7eb3\u57fa\u5965\u4ed1\u8d5b\u3002\u5176\u4e2d\uff0c\u963f\u57fa\u4ed1\u8d5b\u5f15\u8fdb\u81ea\u5409\u5229\u5fb7\u5b50\u516c\u53f8Kite\u5236\u836f\u7684Yescarta\u6280\u672f\uff0c\u8fd9\u4e00\u6280\u672f\u5df2\u5728\u7f8e\u56fdFDA\u9ed1\u6846\u8b66\u544a\u540d\u5355\u4e0a\u3002\u76ee\u524d\u6709\u5173\u90e8\u95e8\u8fd8\u6ca1\u6709\u5c31\u6709\u5173CAR-T\u836f\u7269\u6cbb\u7597\u540e\u51fa\u73b0\u7b2c\u4e8c\u79cd\u764c\u75c7\u7684\u60c5\u51b5\u53d1\u8868\u610f\u89c1\u3002\u4e1a\u754c\u5bf9\u4e8e\u7ba1\u7406\u90e8\u95e8\u662f\u5426\u4f1a\u501f\u9274FDA\u7684\u8c03\u67e5\uff0c\u5bf9\u56fd\u5185\u7684\u51e0\u6b3e\u5df2\u6279\u51c6\u7684CAR-T\u836f\u7269\u662f\u5426\u8fdb\u884c\u9ed1\u6846\u8b66\u544a\u6216\u8981\u6c42\u8fdb\u884c\u7c7b\u4f3c\u7684\u957f\u671f\u526f\u4f5c\u7528\u8bd5\u9a8c\u4e0e\u62a5\u544a\uff0c\u503c\u5f97\u89c2\u5bdf\u3002<\/p>\n\n\n\n<p>\u3000<strong>120\u4e07\u4e00\u9488\u5929\u4ef7\u6297\u764c\u795e\u836f CAR-T \u4f1a\u5bfc\u81f4\u7b2c\u4e8c\u79cd\u764c\u75c7\uff1fFDA\u6536\u5230 25 \u4f8b\u62a5\u544a\uff0c\u6025\u4ee4\u6dfb\u52a0\u9ed1\u6846\u8b66\u544a\uff0c\u8be5\u8b66\u544a\u4e2d\u6d89\u53ca\u4e2d\u56fd\u7684\u4e00\u6b3e\u836f\u7269<\/strong><\/p>\n\n\n\n<p>\u3000\u3000\u5728\u56fd\u5185\u66fe\u4ee5120\u4e07\u5143\u4e00\u9488\u5929\u4ef7\u6297\u764c\u795e\u836f\u95fb\u540d\u7684CAR-T\u514d\u75ab\u7597\u6cd5\uff0c\u81ea\u53bb\u5e7411\u6708\u6df1\u9677\u81f4\u764c\u98ce\u6ce2\u540e\uff0c\u518d\u9047\u56f0\u5883.<\/p>\n\n\n\n<p>\u3000\u30001\u670819\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u7d27\u6025\u53d1\u5e03\u8b66\u544a\uff0c\u63a5\u53d7CAR-T \u7ec6\u80de\u514d\u75ab\u7597\u6cd5\u7684\u764c\u75c7\u60a3\u8005\u53ef\u80fd\u51fa\u73b0<strong>\u7b2c\u4e8c\u6076\u6027\u80bf\u7624\uff08T\u7ec6\u80de\u6076\u6027\u80bf\u7624\uff09<\/strong>\u3002<\/p>\n\n\n\n<p>\u3000\u30001\u670824\u65e5\uff0cFDA \u53d1\u8a00\u4eba\u5361\u8389\u00b7\u666e\u592b\u52b3\u59c6 (Carly Pflaum) \u8868\u793a\uff0cFDA\u5df2\u5411\u8fd9\u4e9b\u7597\u6cd5\u7684\u6240\u6709\u5236\u9020\u5546\u53d1\u51fa\u4e86\u901a\u77e5\u4fe1\uff0c\u8981\u6c42\u4ed6\u4eec\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u6240\u6709\u516d\u6b3eCAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff0c\u6dfb\u52a0\u989d\u5916\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/p>\n\n\n\n<p>\u3000\u3000<strong>\u9ed1\u6846\u8b66\u544a\u5185\u5bb9\u4e3a\u201c\u4f7f\u7528\u9776\u5411BCMA\u6216CD19\u7684 CAR-T \u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u6cbb\u7597\u540e\uff0c\u53ef\u80fd\u4f1a\u7ee7\u53d1T\u7ec6\u80de\u6076\u6027\u80bf\u7624\u201d<\/strong>\uff0c\u5e76\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u6dfb\u52a0\u6ce8\u610f\u4e8b\u9879\u3001\u4e0d\u826f\u53cd\u5e94\u3001\u60a3\u8005\u54a8\u8be2\u4fe1\u606f\u548c\u60a3\u8005\u533b\u5b66\u6307\u5f15\uff08FDA\u5bf9\u4ea7\u54c1\u8bf4\u660e\u4e66\u7684\u7279\u6b8a\u8981\u6c42\uff09\u7b497\u4e2a\u6761\u76ee\u505a\u4e86\u7edf\u4e00\u5e76\u4e14\u5177\u4f53\u7684\u8981\u6c42\u3002<\/p>\n\n\n\n<p>\u3000\u3000\u5361\u8389\u627f\u8ba4\uff0cFDA\u5df2\u6536\u5230 25 \u4f8b CAR-T \u7ec6\u80de\u514d\u75ab\u7597\u6cd5\u6cbb\u7597\u540e\u51fa\u73b0\u6240\u9012\u4ea4\u7684 \u201cT \u7ec6\u80de\u6076\u6027\u80bf\u7624\u201d\u62a5\u544a\u3002<strong>T\u7ec6\u80de\u6076\u6027\u80bf\u7624\u662f\u9ad8\u5ea6\u4fb5\u88ad\u6027\u7684\u8840\u6db2\u7cfb\u7edf\u80bf\u7624\u3002<\/strong><\/p>\n\n\n\n<p>\u3000\u3000T \u7ec6\u80de\u662f\u767d\u7ec6\u80de\u7684\u4e00\u79cd\uff0c\u662fCAR-T \u7597\u6cd5\u7684\u652f\u67f1\u3002\u8fd9\u4e9b\u6280\u672f\u7684\u5de5\u4f5c\u539f\u7406\u662f\u5229\u7528\u60a3\u8005\u7684 T \u7ec6\u80de\uff0c\u5728\u5b9e\u9a8c\u5ba4\u4e2d\u5bf9\u5176\u8fdb\u884c\u6539\u9020\uff0c\u4f7f\u5176\u80fd\u591f\u653b\u51fb\u764c\u7ec6\u80de\uff0c\u7136\u540e\u901a\u8fc7\u8f93\u6ce8\uff0c\u5c06\u8fd9\u4e9b\u6539\u9020\u540e\u7684 T \u7ec6\u80de\u56de\u8f93\u7ed9\u60a3\u8005\u3002<strong>\u76ee\u524d\uff0c\u5df2\u83b7\u6279\u4e0a\u5e02\u7684CAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u4ec5\u9002\u7528\u4e8e\u8840\u6db2\u80bf\u7624\u60a3\u8005\uff0c\u5982\u6025\u6027\u548c\u6162\u6027\u767d\u8840\u75c5\u3001\u6dcb\u5df4\u7624\u548c\u9aa8\u9ad3\u7624\u7b49\u3002<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img fetchpriority=\"high\" decoding=\"async\" width=\"660\" height=\"666\" src=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199066447366.jpg\" alt=\"\" class=\"wp-image-9584\" style=\"width:780px;height:auto\" srcset=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199066447366.jpg 660w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199066447366-297x300.jpg 297w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199066447366-150x150.jpg 150w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199066447366-585x590.jpg 585w\" sizes=\"(max-width: 660px) 100vw, 660px\" \/><\/figure>\n\n\n\n<p>\u3000<strong>FDA\u76ee\u524d\u6279\u51c6\u7684\u516d\u6b3eCAR-T\u7ec6\u80de\u4ea7\u54c1\u5206\u522b\u662f\uff1a<\/strong><\/p>\n\n\n\n<p>\u3000\u3000<strong>1. Abecma\uff08idecabtagene vicleucel\uff09BMS \u9776\u5411 BCMA<\/strong><\/p>\n\n\n\n<p>\u3000\u3000<strong>2. Breyanzi\uff08lisocabtagene maraleucel\uff09BMS \u9776\u5411CD19<\/strong><\/p>\n\n\n\n<p>\u3000<strong>3. Carvykti\uff08ciltacabtagene autoleucel\uff09\u5f3a\u751f\/\u4f20\u5947 \u9776\u5411BCMA\uff08\u4e2d\u56fd\u516c\u53f8\uff09<\/strong><\/p>\n\n\n\n<p>\u3000\u3000<strong>4. Kymriah\uff08tisagenlecleucel\uff09\u8bfa\u534e \u9776\u5411CD19<\/strong><\/p>\n\n\n\n<p>\u3000\u3000<strong>5. Tecartus\uff08brexucabtagene autoleucel\uff09\u5409\u5229\u5fb7 \u9776\u5411CD19<\/strong><\/p>\n\n\n\n<p>\u3000\u3000<strong>6. Yescarta\uff08axicabtagene ciloleucel\uff09Kite\/\u5409\u5229\u5fb7 \u9776\u5411CD19<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"660\" height=\"362\" src=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067195303.jpg\" alt=\"\" class=\"wp-image-9585\" srcset=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067195303.jpg 660w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067195303-300x165.jpg 300w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067195303-585x321.jpg 585w\" sizes=\"(max-width: 660px) 100vw, 660px\" \/><\/figure>\n\n\n\n<p>\u3000<strong>\u8bfa\u534e\u516c\u53f8\u7684Kymriah \u662fFDA\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u767d\u8840\u75c5\u7684\u7b2c\u4e00\u4e2a CAR-T \u764c\u75c7\u7597\u6cd5\u00a0<\/strong>\uff0c\u4e8e 2017 \u5e74\u83b7\u5f97\u6279\u51c6\u3002\u8fd9\u4e9b\u7597\u6cd5\u7684\u6700\u521d\u6279\u51c6\u5305\u62ec FDA\u6240\u8981\u6c42\u8fdb\u884c\u7684 15 \u5e74\u968f\u8bbf\u7814\u7a76\uff0c\u4ee5\u957f\u671f\u8bc4\u4f30\u5b89\u5168\u6027\u548c\u7ee7\u53d1\u6027\u7684\u6076\u6027\u80bf\u7624\u98ce\u9669\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"660\" height=\"335\" src=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067177217.jpg\" alt=\"\" class=\"wp-image-9586\" srcset=\"https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067177217.jpg 660w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067177217-300x152.jpg 300w, https:\/\/newswz.com\/wp-content\/uploads\/2024\/01\/1706199067177217-585x297.jpg 585w\" sizes=\"(max-width: 660px) 100vw, 660px\" \/><\/figure>\n\n\n\n<p>\u3000\u81ea\u7f8e\u56fd\u7b2c\u4e00\u6b3eCAR-T \u7ec6\u80de\u514d\u75ab\u7597\u6cd5\u83b7\u6279\u516d\u5e74\u540e\uff0c\u7f8e\u56fd\u5df2\u6709\u8d85 27,000 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