{"id":20625,"date":"2024-10-28T11:27:31","date_gmt":"2024-10-28T03:27:31","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=20625"},"modified":"2025-02-09T12:53:46","modified_gmt":"2025-02-09T04:53:46","slug":"fda%e6%89%b9%e5%87%86%e9%98%bf%e6%9b%bf%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97atezolizumab%ef%bc%89%e5%92%8c%e9%80%8f%e6%98%8e%e8%b4%a8%e9%85%b8%e9%85%b6%e7%9a%ae%e4%b8%8b%e6%b3%a8%e5%b0%84pd-l1","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda%e6%89%b9%e5%87%86%e9%98%bf%e6%9b%bf%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97atezolizumab%ef%bc%89%e5%92%8c%e9%80%8f%e6%98%8e%e8%b4%a8%e9%85%b8%e9%85%b6%e7%9a%ae%e4%b8%8b%e6%b3%a8%e5%b0%84pd-l1\/","title":{"rendered":"FDA\u6279\u51c6\u963f\u66ff\u5229\u73e0\u5355\u6297(atezolizumab\uff09\u548c\u900f\u660e\u8d28\u9178\u9176\u76ae\u4e0b\u6ce8\u5c04PD-(L)1\u514d\u75ab\u6cbb\u7597"},"content":{"rendered":"\n

\u7f8e\u56fd\u98df\u54c1\u836f\u7269\u7ba1\u7406\u5c40\uff08\u4e0b\u79f0\u201cFDA\u201d\uff09\u8fd1\u65e5\u6279\u51c6\u4e86\u963f\u66ff\u5229\u73e0\u5355\u6297(atezolizumab)\u548c\u900f\u660e\u8d28\u9178\u9176\u76ae\u4e0b\u6ce8\u5c04PD-(L)1\u514d\u75ab\u6cbb\u7597\u3002\u75c5\u60c5\u9002\u5408\u4f7f\u7528\u963f\u66ff\u5229\u73e0\u5355\u6297\u7684\u75c5\u4eba\uff0c\u4fbf\u591a\u4e86\u9009\u62e9\uff0c\u53ef\u5728\u5927\u7ea67\u5206\u949f\u7684\u65f6\u95f4\u5185\u5b8c\u6210\u76ae\u4e0b\u6ce8\u5c04\uff0c\u6bd4\u8d77\u4f7f\u7528atezolizumab\u7684\u6807\u51c6\u9759\u8109\u7684\u6ce8\u5c04\u65f6\u95f4 (30-60\u5206\u949f)\uff0c\u8282\u7701\u4e862\/3\u7684\u7ed9\u836f\u65f6\u95f4\u3002<\/p>\n\n\n\n

\u65b0\u51fa\u7684atezolizumab\u76ae\u4e0b\u6ce8\u5c04\u5236\u5242\u5728\u7f8e\u56fd\u6240\u83b7\u51c6\u7528\u4e8e\u6210\u4eba\u7684\u6240\u6709\u9759\u8109\u6ce8\u5c04\u9002\u5e94\u75c7\uff0c\u5df2\u88ab\u6279\u51c6\u7528\u4e8e\u67d0\u4e9b\u6700\u5177\u4fb5\u88ad\u6027\u548c\u6700\u96be\u6cbb\u7597\u7684\u764c\u75c7\u3002atezolizumab\u662f\u9996\u4e2a\u83b7\u51c6\u7528\u4e8e\u6cbb\u7597\u67d0\u79cd\u65e9\u671f\uff08\u8f85\u52a9\uff09\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u3001\u5c0f\u7ec6\u80de\u80ba\u764c\uff08SCLC\uff09\u548c\u809d\u7ec6\u80de\u764c\uff08HCC\uff09\u7684\u764c\u75c7\u514d\u75ab\u7597\u6cd5\u3002atezolizumab\u8fd8\u5728\u4e16\u754c\u5404\u56fd\u83b7\u6279\u5355\u72ec\u6216\u4e0e\u9776\u5411\u7597\u6cd5\u548c\/\u6216\u5316\u7597\u8054\u5408\u7528\u4e8e\u6cbb\u7597\u5404\u79cd\u7c7b\u578b\u7684\u8f6c\u79fb\u6027NSCLC\u3001\u67d0\u4e9b\u7c7b\u578b\u7684\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\uff08mUC\uff09\u3001PD-L1\u9633\u6027\u7684\u8f6c\u79fb\u6027\u4e09\u9634\u6027\u4e73\u817a\u764c\uff08TNBC\uff09\u3001BRAF V600\u7a81\u53d8\u9633\u6027\u7684\u665a\u671f\u9ed1\u8272\u7d20\u7624\u548c\u80ba\u6ce1\u8f6f\u7ec4\u7ec7\u8089\u7624\uff08ASPS\uff09\u3002<\/p>\n\n\n\n

FDA\u7684\u6279\u51c6\u662f\u57fa\u4e8eIB\/III\u671fIMSIN001\u7814\u7a76\u7684\u5173\u952e\u6570\u636e\uff0c\u8be5\u7814\u7a76\u663e\u793a\u76ae\u4e0b\u6ce8\u5c04\u65f6\u8840\u6db2\u4e2d\u7684atezolizumab\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\u4e0e\u9759\u8109\u6ce8\u5c04\u5236\u5242\u4e00\u81f4\u3002IMScin002\u4e8c\u671f\u7814\u7a76\u663e\u793a\uff0c\u4e0e\u9759\u8109\u6ce8\u5c04atezolizumab\u76f8\u6bd4\uff0c71%\u7684\u60a3\u8005\u66f4\u9752\u7750atezolizumab and hyaluronidase-tqjs\uff0c\u6700\u5e38\u89c1\u7684\u539f\u56e0\u662f\u7f29\u77ed\u4e86\u95e8\u8bca\u65f6\u95f4\u3001\u589e\u52a0\u4e86\u6cbb\u7597\u671f\u95f4\u7684\u8212\u9002\u5ea6\u548c\u51cf\u5c11\u4e86\u60c5\u7eea\u56f0\u6270\u30025\u540d\u60a3\u8005\u4e2d\u67094\u540d\uff0879%\uff09\u5728\u4f53\u9a8c\u4e86\u4e24\u79cd\u5236\u5242\u540e\uff0c\u9009\u62e9\u4e86atezolizumab and hyaluronidase-tqjs\u7ee7\u7eed\u6cbb\u7597\u3002<\/p>\n\n\n\n

atezolizumab\u662f\u4e00\u79cd\u5355\u514b\u9686\u6297\u4f53\uff0c\u65e8\u5728\u4e0e\u4e00\u79cd\u540d\u4e3aPD-L1\u7684\u86cb\u767d\u8d28\u7ed3\u5408\u3002atezolizumab\u53ef\u4e0e\u80bf\u7624\u7ec6\u80de\u548c\u80bf\u7624\u6d78\u6da6\u514d\u75ab\u7ec6\u80de\u4e0a\u8868\u8fbe\u7684PD-L1\u7ed3\u5408\uff0c\u963b\u65ad\u5176\u4e0ePD-1\u548cB7.1\u53d7\u4f53\u7684\u76f8\u4e92\u4f5c\u7528\u3002\u901a\u8fc7\u6291\u5236 PD-L1\uff0catezolizumab \u53ef\u4ee5\u91cd\u65b0\u6fc0\u6d3b T \u7ec6\u80de\uff0c\u5bf9\u6297\u3002<\/p>\n\n\n\n

\u5173\u4e8eIMSIN001\u7814\u7a76<\/strong><\/strong><\/p>\n\n\n\n

IMSIN001\u662f\u4e00\u9879IB\/III\u671f\u3001\u5168\u7403\u6027\u3001\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30atezolizumab and hyaluronidase-tqjs\u4e0e\u9759\u8109\u6ce8\u5c04atezolizumab\u76f8\u6bd4\uff0c\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u94c2\u7c7b\u6cbb\u7597\u5931\u8d25\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u4e2d\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u8be5\u7814\u7a76\u5171\u62db\u52df\u4e86 371 \u540d\u60a3\u8005\uff0c\u800c\u8be5\u7814\u7a76\u7684\u7ed3\u679c\u8fbe\u5230\u4e86\u4e3b\u8981\u7ec8\u70b9\uff0c\u6839\u636e\u65e2\u5b9a\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u6d4b\u91cf\u7ed3\u679c\uff0c\u5728\u7ed9\u836f\u95f4\u9694\u671f\u95f4\uff0c\u89c2\u5bdf\u5230\u7684\u7597\u6548\uff08\u4ee5\u603b\u53cd\u5e94\u7387\u3001\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u3001\u603b\u751f\u5b58\u671f\u548c\u53cd\u5e94\u6301\u7eed\u65f6\u95f4\u8861\u91cf\uff09\u5728\u9759\u8109\u6ce8\u5c04\u548c\u9759\u8109\u6ef4\u6ce8\u6cbb\u7597\u7ec4\u4e4b\u95f4\u76f8\u4f3c\uff0c\u5e76\u4e14\u4e0e\u5df2\u77e5\u7684\u9759\u8109\u6ef4\u6ce8atezolizumab\u7684\u60c5\u51b5\u4e00\u81f4\u3002\u6545\u6b64\uff0catezolizumab and hyaluronidase-tqjs\u7684\u5b89\u5168\u6027\u4e5f\u4e0e\u9759\u8109\u6ce8\u5c04atezolizumab\u4e00\u81f4\u3002<\/p>\n\n\n\n

\u6b64\u836f\u662f\u57fa\u4e8e\u4e00\u79cd\u4e13\u6709\u7684\u91cd\u7ec4\u4eba\u900f\u660e\u8d28\u9178\u9176PH20\uff08rHuPH20\uff09\uff0c\u8fd9\u79cd\u9176\u80fd\u5728\u76ae\u4e0b\u5c40\u90e8\u6682\u65f6\u964d\u89e3\u900f\u660e\u8d28\u9178\uff08\u4eba\u4f53\u5185\u7684\u4e00\u79cd\u7cd6\u80fa\u805a\u7cd6\u6216\u5929\u7136\u7cd6\u94fe\uff09\uff0c\u4ece\u800c\u589e\u52a0\u76ae\u4e0b\u7ec4\u7ec7\u7684\u901a\u900f\u6027\uff0c\u4e3aatezolizumab\u7684\u8fdb\u5165\u7559\u51fa\u7a7a\u95f4\uff0c\u4f7f\u5176\u8fc5\u901f\u5206\u6563\u5e76\u88ab\u8840\u6db2\u5438\u6536\u3002<\/p>\n\n\n\n

\u5173\u4e8e IMscin002 \u7814\u7a76<\/strong><\/strong><\/p>\n\n\n\n

IMScin002\u662f\u4e00\u9879II\u671f\u5168\u7403\u4ea4\u53c9\u7814\u7a76\uff0c\u8bc4\u4f30\u60a3\u8005\u5bf9\u963f\u7279\u73e0\u5355\u6297SC\u548cIV\u5236\u5242\u7684\u504f\u597d\u3002\u8be5\u7814\u7a76\u5171\u62db\u52df\u4e86179\u540d\u60a3\u8005\uff0c\u5305\u62ecPD-L1\u9633\u6027\u3001\u5df2\u5b8c\u6210\u94c2\u7c7b\u8f85\u52a9\u5316\u7597\u4e14\u65e0\u75be\u75c5\u590d\u53d1\u8bc1\u636e\u7684II-IIIB\u671fNSCLC\u5207\u9664\u60a3\u8005\uff0c\u4ee5\u53ca\u672a\u7ecf\u6cbb\u7597\u7684PD-L1\u9ad8IV\u671fNSCLC\u60a3\u8005\u3002\u7814\u7a76\u7ed3\u679c\u8fbe\u5230\u4e86\u4e3b\u8981\u7ec8\u70b9\uff0c\u7ed3\u679c\u663e\u793a71%\u7684\u53c2\u4e0e\u8005\u504f\u597dSC\u5236\u5242\uff0821%\u504f\u597d\u9759\u8109\u6ce8\u5c04\uff0c8%\u8868\u793a\u65e0\u504f\u597d\uff09\uff1b79%\u7684\u53c2\u4e0e\u8005\u5728\u4f53\u9a8c\u4e86\u4e24\u79cd\u5236\u5242\u7684atezolizumab\u540e\uff0c\u9009\u62e9\u4e86atezolizumab and hyaluronidase-tqjs\u6765\u5b8c\u6210\u6cbb\u7597\u3002\u7814\u7a76\u8bc1\u5b9e\uff0c\u5728atezolizumab and hyaluronidase-tqjs\u4e0e\u9759\u8109\u6ce8\u5c04atezolizumab\u4e4b\u95f4\u5207\u6362\u7684\u8010\u53d7\u6027\u826f\u597d\uff0c\u6ca1\u6709\u51fa\u73b0\u65b0\u7684\u5b89\u5168\u4fe1\u53f7\u3002<\/p>\n\n\n\n

\u53c2\u8003\u6765\u6e90\uff1a<\/strong><\/p>\n\n\n\n

https:\/\/www.drugs.com\/newdrugs\/fda-approves-tecentriq-hybreza-atezolizumab-hyaluronidase-tqjs-subcutaneous-anti-pd-l-1-cancer-6365.html<\/p>\n\n\n\n

\u8f6c\u8f7d\u8bf7\u8054\u7cfb\u6388\u6743\uff0c\u6216\u6ce8\u660e\u6765\u6e90<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

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