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\u94fe\u63a5\uff1a2017\u5e74\u7f8e\u5723\u5730\u4e9a\u54e5\u751f\u836f\u6280\u672f\u9886\u57df\u6377\u62a5\u9891\u4f20\uff08\u4e00\uff09<\/a>
\n\u94fe\u63a5\uff1a2017\u5e74\u7f8e\u5723\u5730\u4e9a\u54e5\u751f\u836f\u6280\u672f\u9886\u57df\u6377\u62a5\u9891\u4f20\uff08\u4e8c\uff09<\/a><\/p>\n

\u836f\u660e\u5eb7\u5fb7\u62a5\u9053\uff1a<\/p>\n

\u8bfa\u534e\u9996\u6b3eCAR-T\u7597\u6cd5\u4eca\u65e5\u83b7\u7f8e\u56fdFDA\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c<\/span><\/h4>\n

\"\"<\/a>\u8bfa\u534e<\/strong>\u65e5\u524d\u5ba3\u5e03\u7f8e\u56fdFDA\u5df2\u4e3a\u5176CAR-T\u7597\u6cd5CTL019\uff08tisagenlecleucel-T\uff09\u7684\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\u9881\u53d1\u4e86\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c<\/strong>\u3002\u8fd9\u610f\u5473\u7740\u8bfa\u534e\u9996\u6b3eCAR-T\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\u7684\u5ba1\u6279\u6d41\u7a0b\u6709\u671b\u5f97\u5230\u8fdb\u4e00\u6b65\u7684\u7f29\u51cf\u3002<\/p>\n

CTL019\u6700\u521d\u7531\u5bbe\u5915\u6cd5\u5c3c\u4e9a\u5927\u5b66\u5f00\u53d1\u30022012\u5e74\uff0c\u8bfa\u534e\u4e0e\u5bbe\u5915\u6cd5\u5c3c\u4e9a\u5927\u5b66\u8fbe\u6210\u5168\u7403\u5408\u4f5c\u534f\u8bae\uff0c\u5171\u540c\u7814\u7a76\u3001\u5f00\u53d1\u4e0e\u5546\u4e1a\u5316\u5305\u62ecCTL019\u5728\u5185\u7684\u591a\u9879CAR-T\u7597\u6cd5\uff0c\u7528\u4ee5\u764c\u75c7\u6cbb\u7597\u3002\u76ee\u524d\uff0cCTL019\u7533\u8bf7\u4e0a\u5e02\u7684\u9002\u5e94\u75c7\u4e3a\u513f\u7ae5\u6216\u5e74\u8f7b\u4eba\u4e2d\u590d\u53d1\u6216\u96be\u6cbb\u6027\u7684\u6025\u6027B\u7ec6\u80de\u578b\u6dcb\u5df4\u6027\u767d\u8840\u75c5\uff08B-cell acute lymphoblastic leukemia\uff09<\/strong><\/p>\n

\"\"<\/a>\u25b2CAR-T\u7597\u6cd5\u5148\u9a71\u4e4b\u4e00Carl June\u6559\u6388\u8ba4\u4e3a\u7ec6\u80de\u7597\u6cd5\u5728\u8fd1\u51e0\u5e74\u6765\u53d6\u5f97\u4e86\u5de8\u5927\u8fdb\u5c55\uff08\u56fe\u7247\u6765\u6e90\uff1a\u5bbe\u5915\u6cd5\u5c3c\u4e9a\u5927\u5b66\uff09<\/strong><\/p>\n

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\u5728\u5148\u524d\u4e00\u9879\u540d\u4e3aELIANA\u76842\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0cCTL019\u53d6\u5f97\u4e86\u826f\u597d\u7684\u7597\u6548\u3002\u4e00\u5171\u670950\u540d\u60a3\u8005\u53c2\u4e0e\u4e86\u8fd9\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u800c\u5728\u63a5\u53d7CTL019\u6cbb\u7597\u76843\u4e2a\u6708\u540e\uff0c\u9ad8\u8fbe82%\u7684\u60a3\u8005\u7684\u75c7\u72b6\u51fa\u73b0\u4e86\u5b8c\u5168\u7f13\u89e3\uff0c\u6216\u5168\u8840\u7ec6\u80de\u8ba1\u6570\u4e0d\u5168\u7684\u5b8c\u5168\u7f13\u89e3<\/strong>\u3002\u6cbb\u7597\u540e\uff0c\u6ca1\u6709\u4e00\u540d\u60a3\u8005\u56e0\u201c\u7ec6\u80de\u56e0\u5b50\u98ce\u66b4\u201d\uff08cytokine release syndrome\uff09\u6b7b\u4ea1\u3002\u53bb\u5e7412\u6708\uff0c\u8fd9\u9879\u7814\u7a76\u4e5f\u5728\u7f8e\u56fd\u8840\u6db2\u5b66\u5b66\u4f1a\uff08American Society of Hematology\uff09\u7684\u5927\u4f1a\u4e0a\u5f97\u5230\u62a5\u9053\u3002<\/p>\n

\"\"<\/a>\u25b2CTL019\u7684\u6cbb\u7597\u6d41\u7a0b\uff08\u56fe\u7247\u6765\u6e90\uff1a\u8bfa\u534e\u5b98\u7f51\uff09<\/strong><\/p>\n

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\u53c2\u8003\u8d44\u6599\uff1a<\/p>\n

[1] Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r\/r B-cell ALL granted FDA Priority Review<\/p>\n

[2] \u8bfa\u534e\u5b98\u65b9\u7f51\u7ad9<\/p>\n

FDA\u4eca\u65e5\u6279\u51c640\u5e74\u6765\u9996\u6b3e\u4e25\u91cd\u591a\u53d1\u6027\u786c\u5316\u75c7\u65b0\u836f<\/span><\/h3>\n

\u4eca\u5929\uff0c\u7f57\u6c0f\u96c6\u56e2\u6210\u5458Genentech\u516c\u53f8\u5ba3\u5e03\uff0c\u7f8e\u56fdFDA\u6279\u51c6OCREVUS\uff08 ocrelizumab\uff09\u4f5c\u4e3a\u9996\u4e2a\u88ab\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6027\u53ca\u539f\u53d1\u6027\u8fdb\u5c55\u578b\u591a\u53d1\u6027\u786c\u5316\u75c7\u7684\u65b0\u836f<\/strong>\u3002\u7edd\u5927\u591a\u6570\u7684\u591a\u53d1\u6027\u786c\u5316\u75c7\u60a3\u8005\u5728\u786e\u8bca\u65f6\u90fd\u4f1a\u4f34\u968f\u590d\u53d1\u6027\u548c\u539f\u53d1\u6027\u8fdb\u5c55\u578b\u786c\u5316\u75c7\u7684\u75c7\u72b6\u3002<\/p>\n

\"\"<\/a><\/p>\n

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\"\"<\/a><\/p>\n

OCREVUS\uff08ocrelizumab\uff09\u662f\u4e00\u79cd\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\uff0c\u88ab\u8bbe\u8ba1\u7528\u4e8e\u9009\u62e9\u6027\u9776\u5411CD20\u9633\u6027B\u7ec6\u80de\u3002\u8fd9\u4e00\u7279\u5b9a\u7c7b\u578b\u7684\u514d\u75ab\u7ec6\u80de\u88ab\u8ba4\u4e3a\u662f\u9020\u6210\u9ad3\u78f7\u8102\uff08\u6709\u7edd\u7f18\u548c\u652f\u6301\u795e\u7ecf\u7ec6\u80de\u529f\u80fd\uff09\u548c\u8f74\u7a81\uff08\u4e5f\u5c31\u662f\u795e\u7ecf\u7ec6\u80de\uff09\u635f\u4f24\u7684\u5173\u952e\u6027\u56e0\u7d20\uff1b\u800c\u8fd9\u7c7b\u795e\u7ecf\u7ec6\u80de\u635f\u4f24\u53ef\u5bfc\u81f4MS\u60a3\u8005\u7684\u6b8b\u75be\u3002\u57fa\u4e8e\u4e34\u5e8a\u524d\u7814\u7a76\u7ed3\u679c\uff0cOCREVUS\u7ed3\u5408\u5230\u67d0\u4e9b\u8868\u8fbeCD20\u8868\u9762\u86cb\u767d\u7684B\u7ec6\u80de\u4e0a\uff0c\u4f46\u4e0d\u7ed3\u5408\u5e72\u7ec6\u80de\u6216\u6d46\u7ec6\u80de\uff0c\u56e0\u6b64\u4e5f\u4fdd\u62a4\u4e86\u514d\u75ab\u7cfb\u7edf\u7684\u91cd\u8981\u529f\u80fd<\/strong>\u3002OCREVUS\u901a\u8fc7\u6bcf\u516d\u4e2a\u6708\u9759\u8109\u8f93\u6ce8\u4e00\u6b21\u7ed9\u836f\u3002\u7b2c\u4e00\u5242\u7ed9\u4e88\u4e24\u6b21300mg\u8f93\u6ce8\uff0c\u95f4\u9694\u4e24\u5468\u3002\u968f\u540e\u7684\u5242\u91cf\u4ee5\u5355\u6b21600mg\u5242\u91cf\u8f93\u6ce8\u7ed9\u4e88\u3002<\/p>\n

Ocrevus\u6cbb\u7597\u590d\u53d1\u6027\u591a\u53d1\u6027\u786c\u5316\u75c7\uff08RMS\uff09\u7684\u7597\u6548\u5728\u6d89\u53ca1656\u540d\u53c2\u4e0e\u8005\u3001\u4e24\u9879\u957f\u8fbe96\u5468\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u4ee5\u9a8c\u8bc1\u3002\u4e0e\u53e6\u4e00\u79cdMS\u836f\u7269\u5e72\u6270\u7d20\u03b2-1a\u76f8\u6bd4\uff0c\u63a5\u53d7Ocrevus\u7684\u60a3\u8005\u5177\u6709\u663e\u8457\u964d\u4f4e\u7684\u590d\u53d1\u7387\u548c\u6b8b\u75be\u6076\u5316\u7a0b\u5ea6\u7684\u51cf\u5c11\u3002\u5728\u6709732\u540d\u60a3\u8005\u53c2\u52a0\u7684PPMS\u7814\u7a76\u4e2d\uff0c\u53d7\u8bd5\u8005\u8fdb\u884c\u4e86\u81f3\u5c11120\u5468\u7684\u7528\u836f\uff0c\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u63a5\u53d7Ocrevus\u7684\u60a3\u8005\u663e\u8457\u5ef6\u957f\u4e86\u6b8b\u75be\u6076\u5316\u7684\u65f6\u95f4\u3002FDA\u66fe\u5411\u8fd9\u4e00\u83b7\u6279\u7684\u9002\u5e94\u8bc1\u9881\u53d1\u4e86\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u3001\u5feb\u901f\u901a\u9053\u548c\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002OCREVUS\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u4e5f\u5df2\u83b7\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u7684\u6279\u51c6\uff0c\u76ee\u524d\u6b63\u5728\u5ba1\u6838\u6d41\u7a0b\u4e2d\u3002<\/p>\n

\u7f57\u6c0f\u9996\u5e2d\u533b\u5b66\u5b98\u517c\u5168\u7403\u4ea7\u54c1\u53d1\u5c55\u8d1f\u8d23\u4ebaSandra Horning\u535a\u58eb\u8868\u793a\uff1a\u201cFDA\u6279\u51c6OCREVUS\uff0c\u5bf9MS\u60a3\u8005\u7fa4\u4f53\u6765\u8bf4\u610f\u5473\u7740\u65b0\u65f6\u4ee3\u7684\u5f00\u59cb\uff0c\u4e5f\u4ee3\u8868\u7740\u4e00\u6d41B\u7ec6\u80de\u9776\u5411\u6cbb\u7597\u7684\u91cd\u5927\u79d1\u5b66\u8fdb\u6b65\u3002\u5230\u76ee\u524d\u4e3a\u6b62\uff0c\u6ca1\u6709\u83b7\u5f97FDA\u6279\u51c6\u7684\u6cbb\u7597\u65b9\u6cd5\u53ef\u9002\u7528\u4e8e\u539f\u53d1\u6027\u8fdb\u5c55\u578b\u591a\u53d1\u6027\u786c\u5316\u75c7\u60a3\u8005\u3002\u6211\u4eec\u76f8\u4fe1\u6bcf\u516d\u4e2a\u6708\u4e00\u6b21\u7684OCREVUS\u65bd\u836f\uff0c\u6709\u53ef\u80fd\u6539\u53d8MS\u60a3\u8005\u7684\u75be\u75c5\u8fdb\u7a0b\uff0c\u6211\u4eec\u81f4\u529b\u4e8e\u5e2e\u52a9\u90a3\u4e9b\u53ef\u4ee5\u83b7\u76ca\u4e8e\u8be5\u521b\u65b0\u7597\u6cd5\u7684\u75c5\u4eba\u3002\u201c<\/p>\n

FDA\u836f\u7269\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3\u795e\u7ecf\u75c5\u5b66\u4ea7\u54c1\u90e8\u95e8\u7684\u4e3b\u4efbBilly Dunn\u535a\u58eb\u8bf4\u9053\uff1a\u201c\u591a\u53d1\u6027\u786c\u5316\u75c7\u53ef\u5bf9\u75c5\u4eba\u7684\u751f\u547d\u4ea7\u751f\u6df1\u8fdc\u7684\u5f71\u54cd\u3002\u8fd9\u4e00\u65b0\u7684\u65b9\u6cd5\u4e0d\u4ec5\u4e3a\u590d\u53d1\u578bMS\u60a3\u8005\u63d0\u4f9b\u4e86\u53e6\u4e00\u79cd\u6cbb\u7597\u65b9\u6848\uff0c\u800c\u4e14\u9996\u6b21\u4e3a\u539f\u53d1\u8fdb\u884c\u578bMS\u60a3\u8005\u63d0\u4f9b\u4e86\u4e00\u79cd\u83b7\u5f97\u8ba4\u53ef\u7684\u6cbb\u7597\u65b9\u6848\u3002\u201d<\/p>\n

\u53c2\u8003\u8d44\u6599\uff1a<\/p>\n

[1] FDA Approves Genentech\u2019s OCREVUS\u2122 (Ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis<\/p>\n

[2] FDA approves new drug to treat multiple sclerosis<\/p>\n

 <\/p>\n

\"\"<\/a> \"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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