{"id":41148,"date":"2026-07-23T17:36:39","date_gmt":"2026-07-23T09:36:39","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=41148"},"modified":"2026-07-23T17:36:52","modified_gmt":"2026-07-23T09:36:52","slug":"fda%e6%89%b9%e5%87%86isatuximab-irfc%e7%9a%ae%e4%b8%8b%e6%b3%a8%e5%b0%84%e5%89%82%e5%9e%8b%e6%b2%bb%e7%96%97%e5%a4%9a%e5%8f%91%e6%80%a7%e9%aa%a8%e9%ab%93%e7%98%a4%ef%bc%8c%e5%88%9b%e6%96%b0%e7%bb%99","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda%e6%89%b9%e5%87%86isatuximab-irfc%e7%9a%ae%e4%b8%8b%e6%b3%a8%e5%b0%84%e5%89%82%e5%9e%8b%e6%b2%bb%e7%96%97%e5%a4%9a%e5%8f%91%e6%80%a7%e9%aa%a8%e9%ab%93%e7%98%a4%ef%bc%8c%e5%88%9b%e6%96%b0%e7%bb%99\/","title":{"rendered":"FDA\u6279\u51c6isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u6cbb\u7597\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff0c\u521b\u65b0\u7ed9\u836f\u65b9\u5f0f\u63d0\u5347\u6cbb\u7597\u4fbf\u5229\u6027"},"content":{"rendered":"\n

2026\u5e747\u67089\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b<\/strong>\u7528\u4e8e\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff08multiple myeloma\uff09\u7684\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u6b64\u6b21\u6279\u51c6\u5e26\u6765\u7684\u4e3b\u8981\u53d8\u5316\u5e76\u975e\u65b0\u7684\u6cbb\u7597\u9776\u70b9\uff0c\u800c\u662f\u7ed9\u836f\u65b9\u5f0f\u7684\u9769\u65b0<\/strong>\u3002\u6b64\u524d\uff0c\u60a3\u8005\u63a5\u53d7isatuximab-irfc\u6cbb\u7597\u9700\u8981\u901a\u8fc7\u9759\u8109\u8f93\u6ce8\u5b8c\u6210\uff0c\u800c\u6b64\u6b21\u83b7\u6279\u7684\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u53ef\u901a\u8fc7\u8d34\u9644\u4e8e\u60a3\u8005\u8eab\u4f53\u7684\u81ea\u52a8\u7ed9\u836f\u88c5\u7f6e\u5b8c\u6210\u7ed9\u836f\uff0c\u4f7f\u6cbb\u7597\u8fc7\u7a0b\u66f4\u52a0\u4fbf\u6377\uff0c\u6709\u671b\u51cf\u5c11\u8f93\u6db2\u65f6\u95f4\uff0c\u63d0\u9ad8\u60a3\u8005\u6cbb\u7597\u4f53\u9a8c\u3002<\/p>\n\n\n\n

\u6b64\u6b21\u6279\u51c6\u8986\u76d6\u4e09\u79cd\u6cbb\u7597\u65b9\u6848\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e0e\u6cca\u9a6c\u5ea6\u80fa\uff08pomalidomide\uff09\u548c\u5730\u585e\u7c73\u677e\uff08dexamethasone\uff09<\/strong>\u8054\u5408\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u81f3\u5c111\u7ebf\u6cbb\u7597\uff08\u5305\u62ec\u6765\u90a3\u5ea6\u80fa\u548c\u86cb\u767d\u9176\u4f53\u6291\u5236\u5242\u6cbb\u7597\uff09\u7684\u6210\u4eba\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e0e\u5361\u975e\u4f50\u7c73\uff08carfilzomib\uff09\u548c\u5730\u585e\u7c73\u677e<\/strong>\u8054\u5408\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d71\u81f33\u7ebf\u6cbb\u7597\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u6210\u4eba\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e0e\u787c\u66ff\u4f50\u7c73\uff08bortezomib\uff09\u3001\u6765\u90a3\u5ea6\u80fa\uff08lenalidomide\uff09\u548c\u5730\u585e\u7c73\u677e<\/strong>\u8054\u5408\uff0c\u7528\u4e8e\u6cbb\u7597\u4e0d\u9002\u5408\u63a5\u53d7\u81ea\u4f53\u9020\u8840\u5e72\u7ec6\u80de\u79fb\u690d\uff08ASCT\uff09\u7684\u65b0\u8bca\u65ad\u6210\u4eba\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\u3002<\/p>\n\n\n\n

1. <\/strong>Isatuximab-irfc\uff1a\u9776\u5411CD38\u7684\u5355\u514b\u9686\u6297\u4f53\u6cbb\u7597<\/strong><\/strong><\/p>\n\n\n\n

\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u662f\u4e00\u79cd\u6765\u6e90\u4e8e\u6d46\u7ec6\u80de\u7684\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u80bf\u7624\uff0c\u5176\u7279\u70b9\u662f\u5f02\u5e38\u6d46\u7ec6\u80de\u5728\u9aa8\u9ad3\u5185\u5927\u91cf\u589e\u6b96\uff0c\u5bfc\u81f4\u9aa8\u635f\u5bb3\u3001\u8d2b\u8840\u3001\u80be\u529f\u80fd\u5f02\u5e38\u4ee5\u53ca\u514d\u75ab\u529f\u80fd\u4e0b\u964d\u7b49\u95ee\u9898\u3002<\/p>\n\n\n\n

CD38\u662f\u4e00\u79cd\u9ad8\u5ea6\u8868\u8fbe\u4e8e\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7ec6\u80de\u8868\u9762\u7684\u8de8\u819c\u7cd6\u86cb\u767d\uff0c\u662f\u76ee\u524d\u91cd\u8981\u7684\u6cbb\u7597\u9776\u70b9\u4e4b\u4e00\u3002<\/p>\n\n\n\n

Isatuximab-irfc\u662f\u4e00\u79cd\u9776\u5411CD38\u7684\u4eba\u6e90\u5316\u5355\u514b\u9686\u6297\u4f53\uff0c\u53ef\u901a\u8fc7\u591a\u79cd\u514d\u75ab\u673a\u5236\u8bc6\u522b\u5e76\u6e05\u9664\u9aa8\u9ad3\u7624\u7ec6\u80de\uff0c\u5305\u62ec\u8bf1\u5bfc\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u4ecb\u5bfc\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08ADCC\uff09\u3001\u8865\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08CDC\uff09\u4ee5\u53ca\u4fc3\u8fdb\u80bf\u7624\u7ec6\u80de\u51cb\u4ea1\u7b49\u3002<\/p>\n\n\n\n

\u6b64\u524d\uff0cisatuximab-irfc\u5df2\u7ecf\u901a\u8fc7\u9759\u8109\u8f93\u6ce8\u65b9\u5f0f\u8054\u5408\u5176\u4ed6\u6297\u9aa8\u9ad3\u7624\u836f\u7269\u7528\u4e8e\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6cbb\u7597\u3002\u6b64\u6b21\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u83b7\u6279\uff0c\u4e3a\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u52a0\u7075\u6d3b\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

\u6279\u51c6\u4f9d\u636e\uff1a\u591a\u9879\u4e34\u5e8a\u7814\u7a76\u9a8c\u8bc1\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u7597\u6548<\/strong><\/strong><\/p>\n\n\n\n

\u6b64\u6b21FDA\u6279\u51c6\u4e3b\u8981\u57fa\u4e8e\u591a\u9879\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\uff0c\u5305\u62ecIRAKLIA\u3001IZALCO\u4ee5\u53caIsaSocut\u7814\u7a76\u3002<\/p>\n\n\n\n

2. <\/strong>IRAKLIA\u7814\u7a76\uff1a\u76ae\u4e0b\u6ce8\u5c04\u7597\u6548\u4e0e\u9759\u8109\u8f93\u6ce8\u76f8\u5f53<\/strong><\/strong><\/p>\n\n\n\n

Isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u8054\u5408\u6cca\u9a6c\u5ea6\u80fa\u548c\u5730\u585e\u7c73\u677e\u7684\u7597\u6548\uff0c\u5728\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8cIRAKLIA\u7814\u7a76\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\u3002<\/p>\n\n\n\n

\u8be5\u7814\u7a76\u5171\u7eb3\u5165531\u4f8b<\/strong>\u60a3\u8005\uff0c\u5e76\u6309\u71671\u22361\u6bd4\u4f8b\u968f\u673a\u5206\u7ec4\uff0c\u5206\u522b\u63a5\u53d7\uff1a<\/p>\n\n\n\n

\u00b7 <\/strong>isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u8054\u5408\u968f\u8eab\u81ea\u52a8\u7ed9\u836f\u7cfb\u7edf\uff08OBDS\uff09\u6cbb\u7597\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u9759\u8109\u8f93\u6ce8isatuximab-irfc\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u4e24\u7ec4\u60a3\u8005\u5747\u8054\u5408\u6cca\u9a6c\u5ea6\u80fa\u548c\u5730\u585e\u7c73\u677e\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u7814\u7a76\u4e3b\u8981\u8bc4\u4f30\u6307\u6807\u5305\u62ec\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4ee5\u53ca\u836f\u4ee3\u52a8\u529b\u5b66\u8868\u73b0\u3002<\/p>\n\n\n\n

\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u76ae\u4e0b\u6ce8\u5c04\u7ec4\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u8fbe\u523071.1%<\/strong>\uff0c\u9759\u8109\u8f93\u6ce8\u7ec4\u4e3a70.5%<\/strong>\uff0c\u4e24\u79cd\u7ed9\u836f\u65b9\u5f0f\u8868\u73b0\u51fa\u76f8\u8fd1\u7684\u6297\u80bf\u7624\u6548\u679c\u3002\u8be5\u7ed3\u679c\u63d0\u793a\uff0c\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u5728\u4fdd\u6301\u6cbb\u7597\u6548\u679c\u7684\u540c\u65f6\uff0c\u53ef\u4ee5\u63d0\u4f9b\u66f4\u52a0\u4fbf\u5229\u7684\u7ed9\u836f\u65b9\u5f0f\u3002<\/p>\n\n\n\n

3. <\/strong>IZALCO\u7814\u7a76\uff1a\u590d\u53d1\u6216\u96be\u6cbb\u6027\u60a3\u8005\u4e2d\u8868\u73b0\u51fa\u826f\u597d\u7597\u6548<\/strong><\/strong><\/p>\n\n\n\n

Isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u8054\u5408\u5361\u975e\u4f50\u7c73\u548c\u5730\u585e\u7c73\u677e\u7684\u7597\u6548\uff0c\u5728\u2161\u671fIZALCO\u7814\u7a76\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\u3002\u8be5\u7814\u7a76\u7eb3\u516574\u4f8b<\/strong>\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\u3002<\/p>\n\n\n\n

\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u76ae\u4e0b\u6ce8\u5c04isatuximab-irfc\u8054\u5408\u6cbb\u7597\u65b9\u6848\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u8fbe\u523079.7%<\/strong>\uff0c\u63d0\u793a\u8be5\u65b9\u6848\u5728\u7ecf\u8fc7\u591a\u7ebf\u6cbb\u7597\u540e\u7684\u60a3\u8005\u7fa4\u4f53\u4e2d\u4ecd\u5177\u6709\u8f83\u597d\u7684\u6297\u80bf\u7624\u6d3b\u6027\u3002<\/p>\n\n\n\n

4. <\/strong>IsaSocut\u7814\u7a76\uff1a\u65b0\u8bca\u65ad\u60a3\u8005\u4e2d\u83b7\u5f97\u8f83\u9ad8\u7f13\u89e3\u7387<\/strong><\/strong><\/p>\n\n\n\n

\u6b64\u5916\uff0cIsatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u8054\u5408\u787c\u66ff\u4f50\u7c73\u3001\u6765\u90a3\u5ea6\u80fa\u548c\u5730\u585e\u7c73\u677e\u6cbb\u7597\u4e0d\u9002\u5408\u63a5\u53d7\u81ea\u4f53\u9020\u8840\u5e72\u7ec6\u80de\u79fb\u690d\u7684\u65b0\u8bca\u65ad\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\u7684\u7597\u6548\uff0c\u5728\u2161\u671fIsaSocut\u7814\u7a76\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\u3002<\/p>\n\n\n\n

\u8be5\u7814\u7a76\u5171\u7eb3\u516574\u4f8b<\/strong>\u60a3\u8005\uff0c\u672a\u8bbe\u7f6e\u5bf9\u7167\u7ec4\u3002<\/p>\n\n\n\n

\u7814\u7a76\u7ed3\u679c\u663e\u793a\uff0c\u8be5\u6cbb\u7597\u65b9\u6848\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u8fbe\u523097.3%<\/strong>\uff0c\u663e\u793a\u51fa\u8f83\u9ad8\u7684\u75be\u75c5\u63a7\u5236\u6548\u679c\u3002<\/p>\n\n\n\n

5. <\/strong>\u5b89\u5168\u6027\uff1a\u9700\u5173\u6ce8\u611f\u67d3\u53ca\u514d\u75ab\u76f8\u5173\u4e0d\u826f\u53cd\u5e94<\/strong><\/strong><\/p>\n\n\n\n

\u6839\u636eFDA\u5904\u65b9\u4fe1\u606f\uff0cisatuximab-irfc\u76f8\u5173\u5b89\u5168\u6027\u8b66\u544a\u548c\u6ce8\u610f\u4e8b\u9879\u5305\u62ec\uff1a<\/p>\n\n\n\n

\u00b7 <\/strong>\u8fc7\u654f\u53cd\u5e94\u53ca\u5176\u4ed6\u7ed9\u836f\u76f8\u5173\u53cd\u5e94\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u611f\u67d3\u98ce\u9669\u589e\u52a0\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u7ee7\u53d1\u6027\u539f\u53d1\u6076\u6027\u80bf\u7624\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u5bf9\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u7ed3\u679c\u7684\u5f71\u54cd\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u80da\u80ce-\u80ce\u513f\u6bd2\u6027\u3002<\/p>\n\n\n\n

\u7531\u4e8eisatuximab-irfc\u4f5c\u7528\u4e8eCD38\u9633\u6027\u7684\u514d\u75ab\u7ec6\u80de\uff0c\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u5f71\u54cd\u6b63\u5e38\u514d\u75ab\u529f\u80fd\uff0c\u56e0\u6b64\u60a3\u8005\u9700\u8981\u5728\u6cbb\u7597\u671f\u95f4\u63a5\u53d7\u8840\u6db2\u5b66\u6307\u6807\u548c\u611f\u67d3\u98ce\u9669\u76d1\u6d4b\u3002<\/p>\n\n\n\n

6. <\/strong>\u7814\u7a76\u610f\u4e49\uff1a\u4ece\u201c\u6cbb\u7597\u6548\u679c\u201d\u5230\u201c\u6cbb\u7597\u4f53\u9a8c\u201d\u7684\u4f18\u5316<\/strong><\/strong><\/p>\n\n\n\n

\u968f\u7740\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u6cbb\u7597\u65b9\u6848\u4e0d\u65ad\u53d1\u5c55\uff0cCD38\u5355\u6297\u5df2\u7ecf\u6210\u4e3a\u91cd\u8981\u6cbb\u7597\u7ec4\u6210\u90e8\u5206\u3002\u7136\u800c\uff0c\u957f\u671f\u6cbb\u7597\u8fc7\u7a0b\u4e2d\uff0c\u9759\u8109\u8f93\u6ce8\u5e26\u6765\u7684\u65f6\u95f4\u6210\u672c\u548c\u533b\u7597\u8d44\u6e90\u538b\u529b\u4ecd\u662f\u60a3\u8005\u9762\u4e34\u7684\u95ee\u9898\u3002<\/p>\n\n\n\n

\u6b64\u6b21isatuximab-irfc\u76ae\u4e0b\u6ce8\u5c04\u5242\u578b\u83b7\u6279\uff0c\u5728\u4fdd\u6301\u539f\u6709\u6cbb\u7597\u6548\u679c\u7684\u57fa\u7840\u4e0a\uff0c\u901a\u8fc7\u81ea\u52a8\u7ed9\u836f\u88c5\u7f6e\u7b80\u5316\u7ed9\u836f\u6d41\u7a0b\uff0c\u6709\u671b\u51cf\u5c11\u60a3\u8005\u5728\u533b\u7597\u673a\u6784\u505c\u7559\u65f6\u95f4\uff0c\u63d0\u9ad8\u6cbb\u7597\u4fbf\u5229\u6027\u3002<\/p>\n\n\n\n

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

[1] FDA. FDA approves isatuximab-irfc subcutaneous injection for multiple myeloma indications. 2026.<\/p>\n\n\n\n

[2] OncLive. FDA Approves Subcutaneous Isatuximab Delivered via On-Body Delivery System for Multiple Myeloma. 2026.<\/p>\n\n\n\n

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