{"id":188377,"date":"2023-10-31T10:00:00","date_gmt":"2023-10-31T02:00:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=188377"},"modified":"2023-10-31T10:00:00","modified_gmt":"2023-10-31T02:00:00","slug":"%e5%9f%ba%e7%9f%b3%e8%97%a5%e6%a5%ad%e5%ae%a3%e4%bd%88%e6%93%87%e6%8d%b7%e7%be%8e%ef%bc%88%e8%88%92%e6%a0%bc%e5%88%a9%e5%96%ae%e6%8a%97%e6%b3%a8%e5%b0%84%e6%b6%b2%ef%bc%89%e6%b2%bb%e7%99%82","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=188377","title":{"rendered":"\u57fa\u77f3\u85e5\u696d\u5ba3\u4f48\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff09\u6cbb\u7642\u5fa9\u767c\u96e3\u6cbb\u6027\u7d50\u5916NK\/T\u7d30\u80de\u6dcb\u5df4\u7624\u7684\u65b0\u9069\u61c9\u75c7\u5728\u4e2d\u570b\u7372\u6279"},"content":{"rendered":"<div>\n<ul type=\"disc\">\n<li><span>\u64c7\u6377\u7f8e<\/span><sup><span>\u00ae<\/span><\/sup><span>\u662f\u5168\u7403\u9996\u500b\u91dd\u5c0d\u5fa9\u767c\u6216\u96e3\u6cbb\u6027\u7d50\u5916<\/span><span>NK\/T<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\uff08<\/span><span>R\/R ENKTL<\/span><span>\uff09\u9069\u61c9\u75c7\u7372\u6279\u7684\u816b\u7624\u514d\u75ab\u6cbb\u7642\u85e5\u7269\u3002<\/span><\/li>\n<li><span>\u9019\u662f\u7e7c<\/span><span>III<\/span><span>\u671f\u548c<\/span><span>IV<\/span><span>\u671f\u975e\u5c0f\u7d30\u80de\u80ba\u764c\uff08<\/span><span>NSCLC<\/span><span>\uff09\u5f8c\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728\u4e2d\u570b\u7372\u6279\u7684\u7b2c\u4e09\u9805\u9069\u61c9\u75c7\uff0c\u4e5f\u662f\u57fa\u77f3\u85e5\u696d\u81ea\u6210\u7acb\u4ee5\u4f86\u7372\u5f97\u7684\u7b2c<\/span><span>12<\/span><span>\u9805\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u6279\u51c6\u3002<\/span><\/li>\n<li><span>GEMSTONE-201<\/span><span>\u7814\u7a76\u7d50\u679c\u986f\u793a\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u4e2d\u5177\u6709\u512a\u7570\u7684\u6297\u816b\u7624\u6d3b\u6027\u3001\u6301\u4e45\u7684\u816b\u7624\u7de9\u89e3\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002<\/span><\/li>\n<li><span>\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5148\u5f8c\u88ab\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08<\/span><span>FDA<\/span><span>\uff09\u548c\u570b\u5bb6\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08<\/span><span>NMPA<\/span><span>\uff09\u6388\u4e88\u7a81\u7834\u6027\u7642\u6cd5\u8a8d\u5b9a\u548c\u7d0d\u5165\u7a81\u7834\u6027\u6cbb\u7642\u85e5\u7269\uff0c\u7528\u65bc\u6cbb\u7642\u6210\u4eba<\/span><span>R\/R ENKTL<\/span><span>\u3002<\/span><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">\u4e2d\u570b\u8607\u5dde<\/span><span class=\"legendSpanClass\">2023\u5e7410\u670831\u65e5<\/span> <span>\/<\/span><span>\u7f8e\u901a\u793e<\/span><span>\/ &#8212; <\/span><span>\u57fa\u77f3\u85e5\u696d\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u4ee3\u78bc\uff1a<\/span><span>2616<\/span><span>\uff09\uff0c\u4e00\u5bb6\u5c08\u6ce8\u65bc<\/span><span>\u7814\u7a76\u958b\u767c\u53ca\u5546\u696d\u5316\u5275\u65b0\u816b\u7624\u514d\u75ab\u7642\u6cd5\u53ca\u7cbe\u6e96\u6cbb\u7642\u85e5\u7269\u7684\u9818\u5148\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\uff0c\u4e2d\u570b\u570b\u5bb6\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08<\/span><span>NMPA<\/span><span>\uff09\u5df2\u6279\u51c6<\/span><span>PD-L1<\/span><span>\u6297\u9ad4\u64c7\u6377\u7f8e<\/span><sup><span>\u00ae<\/span><\/sup><span>\uff08\u8212\u683c\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff09\u7528\u65bc\u6cbb\u7642\u5fa9\u767c\u6216\u96e3\u6cbb\u6027\u7d50\u5916<\/span><span>NK\/T<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\uff08<\/span><span>R\/R ENKTL<\/span><span>\uff09\u60a3\u8005\u3002\u7531\u6b64\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u6210<\/span><span>\u70ba\u5168\u7403\u9996\u500b\u91dd\u5c0d<\/span><span>R\/R ENKTL<\/span><span>\u9069\u61c9\u75c7\u7372\u6279\u7684\u816b\u7624\u514d\u75ab\u6cbb\u7642\u85e5\u7269\u3002<\/span><\/p>\n<p><span>\u57fa\u77f3\u85e5\u696d\u9996\u5e2d\u57f7\u884c\u5b98\u694a\u5efa\u65b0\u535a\u58eb\u8868\u793a\uff1a<\/span><span>\u300c<\/span><span>\u975e\u5e38\u9ad8\u8208\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u518d\u6b21\u7372\u5f97<\/span><span>NMPA<\/span><span>\u7684\u8a8d\u53ef\u3002<\/span><span>R\/R ENKTL<\/span><span>\u9069\u61c9\u75c7\u7684\u6210\u529f\u7372\u6279\uff0c\u4e0d\u50c5\u662f\u7e7c<\/span><span>III<\/span><span>\u671f\u548c<\/span><span>IV<\/span><span>\u671f<\/span><span>NSCLC<\/span><span>\u4e4b\u5f8c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u9054\u6210\u7684\u53c8\u4e00\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u80cc\u5f8c\u66f4\u662f\u51dd\u805a\u4e86\u57fa\u77f3\u5718\u968a\u91dd\u5c0d\u8a72\u7f55\u898b\u75be\u75c5\u7d93\u5e74\u7d2f\u6708\u7684\u63a2\u7d22\u548c\u5275\u65b0\u3002\u6211\u5011\u59cb\u7d42\u5805\u4fe1\uff0c\u764c\u75c7\u60a3\u8005\u672a\u88ab\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u4e0d\u61c9\u56e0\u5176\u7fa4\u9ad4\u5fae\u5c0f\u800c\u88ab\u5ffd\u8996\u3002\u9664\u80ba\u764c\u4ee5\u5916\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u9084\u5c07\u8986\u84cb\u4e00\u7dda\u80c3\u764c\u548c\u98df\u7ba1\u764c\u9019\u6a23\u7684\u5927\u9069\u61c9\u75c7\uff0c\u76ee\u524d\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u6b63\u5728<\/span><span>NMPA<\/span><span>\u5be9\u8a55\u4e2d\u3002\u6b64\u5916\uff0c\u6211\u5011\u4e5f\u5c07\u8207<\/span><span>FDA<\/span><span>\u4fdd\u6301\u7dca\u5bc6\u6e9d\u901a\uff0c\u9032\u4e00\u6b65\u52a0\u901f\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728\u7f8e\u570b\u7684\u8a3b\u518a\u4e0a\u5e02\u9032\u7a0b\u3002<\/span><span>\u300d<\/span><\/p>\n<p><span>\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>GEMSTONE-201<\/span><span>\u4e3b\u8981<\/span><span>\u7814\u7a76\u8005\u3001\u4e2d\u5c71\u5927\u5b78\u9644\u5c6c\u816b\u7624\u91ab\u9662\u9ec3\u6167\u5f37\u6559\u6388\u8868\u793a\uff1a<\/span><span>\u300c<\/span><span>\u611f\u8b1d<\/span><span>NMPA<\/span><span>\u548c\u76f8\u95dc\u90e8\u9580\u5c0d<\/span><span>NK\/T<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\u9019\u985e\u7f55\u898b\u75be\u75c5\u7684\u95dc\u6ce8\u3002\u4e00\u76f4\u4ee5\u4f86\uff0c<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u9762\u81e8\u8457\u6cbb\u7642\u56f0\u5883\uff0c\u7f3a\u4e4f\u6a19\u6e96\u6cbb\u7642\u3002\u8a72\u75be\u75c5\u6cbb\u7652\u7387\u4f4e\uff0c\u60a3\u8005\u751f\u5b58\u671f\u77ed\uff0c\u5b58\u5728\u9ad8\u5ea6\u672a\u88ab\u6eff\u8db3\u7684\u81e8\u5e8a\u9700\u6c42\u3002<\/span><span>GEMSTONE-201<\/span><span>\u7814\u7a76\u6578\u64da\u8868\u660e\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u55ae\u85e5\u5728<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u4e2d\u80fd\u5c55\u73fe\u51fa\u512a\u7570\u7684\u6297\u816b\u7624\u6d3b\u6027\u3001\u6301\u4e45\u7684\u816b\u7624\u7de9\u89e3\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u96a8\u8457\u8a72\u9805\u9069\u61c9\u75c7\u7684\u7372\u6279\uff0c\u6211\u5011\u671f\u5f85\u66f4\u591a<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u80fd\u65e9\u65e5\u7528\u4e0a\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u3002<\/span><span>\u300d<\/span><\/p>\n<p><span>\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u6b64\u6b21\u9069\u61c9\u75c7\u7684\u7372\u6279\u662f\u57fa\u65bc<\/span><span>GEMSTONE-201<\/span><span>\u7814\u7a76\uff0c\u8a72\u7814\u7a76\u65e8\u5728\u8a55\u4f30\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u4f5c<\/span><span>\u70ba\u55ae\u85e5\u6cbb\u7642\u6210\u4eba<\/span><span>R\/R ENKTL<\/span><span>\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002<\/span><span>\u7814\u7a76\u7d50\u679c\u986f\u793a\uff0c\u76f8\u8f03\u65bc\u6b77\u53f2\u5c0d\u7167\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u986f\u8457\u63d0\u9ad8\u4e86\u5ba2\u89c0\u7de9\u89e3\u7387\uff08<\/span><span>ORR<\/span><span>\uff09\uff1b\u5728<\/span><span>78<\/span><span>\u4f8b\u7642\u6548\u53ef\u8a55\u4f30\u7684\u60a3\u8005\u4e2d\uff0c\u7368\u7acb\u5f71\u50cf\u8a55\u4f30\u59d4\u54e1\u6703\uff08<\/span><span>IRRC<\/span><span>\uff09\u8a55\u4f30\u7684<\/span><span>ORR<\/span><span>\u70ba<\/span><span>44.9%<\/span><span>\uff0c\u5176\u4e2d\u5b8c\u5168\u7de9\u89e3\u7387\u9054\u5230<\/span><span>35.9%<\/span><span>\u3002<\/span><span>\u7814\u7a76\u8005\u7684\u5ba2\u89c0\u7de9\u89e3\u7387\u8a55\u4f30\u7d50\u679c\u8207<\/span><span>IRRC<\/span><span>\u8a55\u4f30\u9ad8\u5ea6\u4e00\u81f4\u3002\u540c\u6642\uff0c\u4e9e\u7d44\u5206\u6790\u8868\u660e\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u4e2d\u5177\u6709\u5ee3\u6cdb\u6709\u6548\u6027\uff0c\u5305\u62ec\u63a5\u53d7\u904e\u591a\u7dda\u6cbb\u7642\u7684\u60a3\u8005\u3001\u4e26\u4e14\u4e0d\u8ad6\u524d\u7dda\u662f\u5426\u9054\u5230\u7de9\u89e3\u3002\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u4e2d\u8010\u53d7\u6027\u548c\u5b89\u5168\u6027\u826f\u597d\uff0c\u672a\u767c\u73fe\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u865f\u3002\u8a72<\/span><span>\u7814\u7a76\u7684\u4e3b\u8981\u7d50\u679c\u66fe\u5728<\/span><span>2022<\/span><span>\u5e74<\/span><span>6<\/span><span>\u6708\u7684\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\uff08<\/span><span>ASCO<\/span><span>\uff09\u5e74\u6703\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u5f62\u5f0f\u516c\u4f48\uff0c\u4e26\u65bc<\/span><span>2023<\/span><span>\u5e74<\/span><span>3<\/span><span>\u6708\u5728\u570b\u969b\u77e5\u540d\u7684\u816b\u7624\u5b78\u6b0a\u5a01\u671f\u520a\u300a<\/span><span>Journal of Clinical Oncology<\/span><span>\u300b\uff08<\/span><span>JCO<\/span><span>\uff09\u5168\u6587\u767c\u8868\u3002<\/span><\/p>\n<p><b><span>\u95dc\u65bc\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><\/b><b><span>\uff08\u8212\u683c\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff09<\/span><\/b><\/p>\n<p><span>\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u662f\u7531\u57fa\u77f3\u85e5\u696d<\/span><span>\u7814\u767c\u7684\u6297<\/span><span>PD-L1<\/span><span>\u55ae\u514b\u9686\u6297\u9ad4\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u7684\u958b\u767c\u662f\u57fa\u65bc\u7f8e\u570b<\/span><span>Ligand<\/span><span>\u516c\u53f8\u6388\u6b0a\u5f15\u9032\u7684<\/span><span>OmniRat<sup><span>\u00ae<\/span><\/sup><\/span><span>\u8f49\u57fa\u56e0\u52d5\u7269\u5e73\u53f0\u3002\u8a72\u5e73\u53f0\u53ef\u4e00\u7ad9\u5f0f<\/span><span>\u7522\u751f\u5168\u4eba\u6e90\u6297\u9ad4\u3002\u4f5c\u70ba\u4e00\u7a2e\u5168\u4eba\u6e90\u5168\u9577\u6297<\/span><span>PD-L1<\/span><span>\u55ae\u514b\u9686\u6297\u9ad4\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u662f\u4e00\u7a2e\u6700\u63a5\u8fd1\u4eba\u9ad4\u7684\u5929\u7136<\/span><span>G<\/span><span>\u578b\u514d\u75ab\u7403\u86cb\u767d<\/span><span>4<\/span><span>\uff08<\/span><span>IgG4<\/span><span>\uff09\u55ae\u6297\u85e5\u7269\u3002\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728\u60a3\u8005\u9ad4\u5167<\/span><span>\u7522\u751f\u514d\u75ab\u539f\u6027\u53ca\u76f8\u95dc\u6bd2\u6027\u7684\u98a8\u96aa\u66f4\u4f4e\uff0c\u9019\u4f7f\u5f97\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u8207\u540c\u985e\u85e5\u7269\u76f8\u6bd4\u5177\u6709\u7368\u7279\u512a\u52e2\u3002<\/span><\/p>\n<p><span>\u76ee\u524d\uff0c<\/span><span>NMPA<\/span><span>\u5df2\u6279\u51c6\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u4e09\u9805\u9069\u61c9\u75c7\uff1a\u7528\u65bc\u6cbb\u7642\u540c\u6b65\u6216\u5e8f\u8cab\u653e\u5316\u7642\u5f8c\u672a\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u7684\u3001\u4e0d\u53ef\u5207\u9664\u3001<\/span><span>III<\/span><span>\u671f<\/span><span>NSCLC<\/span><span>\u60a3\u8005\u3001\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u8f49\u79fb\u6027\u9c57\u72c0\u548c\u975e\u9c57\u72c0<\/span><span>NSCLC<\/span><span>\u60a3\u8005\u4ee5\u53ca\u7528\u65bc\u6cbb\u7642<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u3002<\/span><\/p>\n<p><span>\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u7528\u65bc\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u7121\u6cd5\u624b\u8853\u5207\u9664\u7684\u5c40\u90e8<\/span><span>\u665a\u671f\u6216\u8f49\u79fb<\/span><span>\u6027\u80c3<\/span><span>\/<\/span><span>\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u3001\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u7121\u6cd5\u624b\u8853\u5207\u9664\u7684\u5c40\u90e8<\/span><span>\u665a\u671f\uff0c\u5fa9\u767c\u6216\u8f49\u79fb\u6027\u98df\u7ba1\u9c57\u764c\u7684\u9069\u61c9\u75c7\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb\u5df2\u7372<\/span><span>NMPA<\/span><span>\u53d7\u7406\uff0c\u76ee\u524d\u6b63\u5728\u5be9\u8a55\u4e2d\u3002<\/span><\/p>\n<p><span>\u6b64\u5916\uff0c\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40\uff08<\/span><span>EMA<\/span><span>\uff09\u548c\u82f1\u570b\u85e5\u54c1\u548c\u91ab\u7642\u4fdd\u5065\u7528\u54c1\u7ba1\u7406\u5c40\uff08<\/span><span>MHRA<\/span><span>\uff09\u5747\u5df2\u53d7\u7406\u8212\u683c\u5229\u55ae\u6297\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u8f49\u79fb\u6027<\/span><span>NSCLC<\/span><span>\u7684\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb\u3002\u76ee\u524d\uff0c\u5169\u9805\u7533\u8acb\u6b63\u5728\u5be9\u8a55\u904e\u7a0b\u4e2d\u3002<\/span><\/p>\n<p><span>\u57fa\u77f3\u85e5\u696d\u8207\u8f1d\u745e\u9054\u6210\u6230\u7565\u5408\u4f5c\uff0c\u5176\u4e2d\u5305\u62ec\u57fa\u77f3\u85e5\u696d\u8207\u8f1d\u745e\u6295\u8cc7\u5c31\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u5728\u4e2d\u570b\u5927\u9678\u5730\u5340\u7684\u958b\u767c\u548c\u5546\u696d\u5316\uff0c\u4ee5\u53ca\u57fa\u77f3\u85e5\u696d\u8207\u8f1d\u745e\u6295\u8cc7\u5c07\u66f4\u591a\u816b\u7624<\/span><span>\u7522\u54c1\u5f15\u5165\u5927\u4e2d\u83ef\u5730\u5340\u7684\u5408\u4f5c\u6846\u67b6\u9054\u6210\u6230\u7565\u5408\u4f5c\u7b49<\/span><span>\u3002<\/span><\/p>\n<p><b><span>\u95dc\u65bc<\/span><\/b><b><span>GEMSTONE-201<\/span><\/b><b><span>\u7814<\/span><\/b><b><span>\u7a76<\/span><\/b><\/p>\n<p><span>GEMSTONE-201<\/span><span>\u7814\u7a76\u662f\u4e00\u9805\u55ae\u81c2\u3001\u591a\u4e2d\u5fc3\u7684<\/span><span>II<\/span><span>\u671f\u8a3b\u518a\u6027\u81e8\u5e8a<\/span><span>\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u4f5c<\/span><span>\u70ba\u55ae\u85e5\u6cbb\u7642\u6210\u4eba<\/span><span>R\/R ENKTL<\/span><span>\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u57fa\u65bc\u512a\u7570\u7684\u521d\u6b65\u6709\u6548\u6027\u7d50\u679c\uff0c\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u88ab\u7f8e\u570b<\/span><span>FDA<\/span><span>\u6388\u4e88\u5b64\u5152\u85e5\u8cc7\u683c<\/span><span>(Orphan Drug Designation, ODD)<\/span><span>\u548c\u7a81\u7834\u6027\u7642\u6cd5\u8a8d\u5b9a<\/span> <span>(Breakthrough Therapy Designation, BTD<\/span><span>\uff09\u5206\u5225\u7528\u65bc\u6cbb\u7642<\/span><span>T<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\u548c\u6210\u4eba<\/span><span>R\/R ENKTL<\/span><span>\uff0c\u4e26\u88ab\u4e2d\u570b\u570b\u5bb6\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u5be9\u8a55\u4e2d\u5fc3\u7d0d\u5165<\/span><span>\u300c<\/span><span>\u7a81\u7834\u6027\u6cbb\u7642\u85e5\u7269<\/span><span>\u300d<\/span><span>\uff0c\u64ec\u5b9a\u9069\u61c9\u75c7<\/span><span>\u70ba\u5fa9\u767c\u6216\u96e3\u6cbb\u6027\u7d50\u5916<\/span><span>NK\/T<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\u3002<\/span><\/p>\n<p><span>2022<\/span><span>\u5e74<\/span><span>1<\/span><span>\u6708\uff0c<\/span><span>GEMSTONE-201<\/span><span>\u7814\u7a76\u7d93<\/span><span>IRRC<\/span><span>\u8a55\u4f30\u9054\u5230\u4e86\u9810\u8a2d\u7684\u4e3b\u8981<\/span><span>\u7814\u7a76\u7d42\u9ede\u3002<\/span><span>2022<\/span><span>\u5e74<\/span><span>6<\/span><span>\u6708\uff0c<\/span><span>GEMSTONE-201<\/span><span>\u7684\u5b8c\u6574<\/span><span>\u7814\u7a76\u7d50\u679c\u5728\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\uff08<\/span><span>ASCO<\/span><span>\uff09\u5e74\u6703\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u7684\u5f62\u5f0f\u9996\u6b21\u516c\u4f48\u3002<\/span><span>2023<\/span><span>\u5e74<\/span><span>3<\/span><span>\u6708\uff0c\u570b\u969b\u77e5\u540d\u7684\u816b\u7624\u5b78\u6b0a\u5a01\u671f\u520a\u300a<\/span><span>Journal of Clinical Oncology<\/span><span>\u300b\uff08<\/span><span>JCO<\/span><span>\uff09\u767c\u8868\u4e86\u64c7\u6377\u7f8e<sup><span>\u00ae<\/span><\/sup><\/span><span>\u6cbb\u7642<\/span><span>R\/R ENKTL<\/span><span>\u7684\u8a3b\u518a\u6027\u81e8\u5e8a<\/span><span>\u7814\u7a76\uff08<\/span><span>GEMSTONE-201<\/span><span>\uff09\u7d50\u679c\u3002<\/span><\/p>\n<p><b><span>\u95dc\u65bc\u7d50\u5916<\/span><\/b><b><span>NK\/T<\/span><\/b><b><span>\u7d30\u80de\u6dcb\u5df4\u7624\uff08<\/span><\/b><b><span>ENKTL<\/span><\/b><b><span>\uff09<\/span><\/b><\/p>\n<p><span>ENKTL<\/span><span>\u5c6c\u65bc\u6210\u719f<\/span><span>T<\/span><span>\u7d30\u80de\u548c<\/span><span>NK<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\u7684\u4e00\u500b\u4e9e\u578b\u3002\u6211\u570b<\/span><span>2012<\/span><span>\u5e74\u7684\u4e00\u9805\u591a\u4e2d\u5fc3<\/span><span>10,002<\/span><span>\u4f8b\u6dcb\u5df4\u7624\u60a3\u8005\u7684\u75c5\u7406\u5206\u578b\u5206\u6790\u7d50\u679c\u986f\u793a<\/span><span>ENKTL<\/span><span>\u7d04\u5360\u6240\u6709\u6dcb\u5df4\u7624\u7684<\/span><span>6%<\/span><span>\u3001\u6210\u719f<\/span><span>T<\/span><span>\u7d30\u80de\u548c<\/span><span>NK<\/span><span>\u7d30\u80de\u6dcb\u5df4\u7624\u7684<\/span><span>28%<sup>[1]<\/sup><\/span><span>\u3002<\/span><span>ENKTL<\/span><span>\u60a3\u8005\u5728\u63a5\u53d7\u542b\u9580\u51ac<\/span><span>\u9170\u80fa\u9176\u70ba\u57fa\u790e\u7684\u6a19\u6e96\u65b9\u6848\u5f8c\u75be\u75c5\u767c\u751f\u9032\u5c55\uff0c\u7f3a\u4e4f\u6709\u6548\u7684\u633d\u6551\u6cbb\u7642\u624b\u6bb5<\/span><span>, <\/span><span>\u901a\u5e38\u5c0d\u50b3\u7d71\u6cbb\u7642\u53cd\u61c9\u4e0d\u4f73\u3002\u81e8\u5e8a\u91ab\u751f\u5c0d\u65bc\u9019\u985e\u60a3\u8005\u5e38\u5e38\u675f\u624b\u7121\u7b56\uff0c\u56e0\u60e1\u6027\u7a0b\u5ea6\u9ad8\u4e14\u4fb5\u8972\u6027<\/span><span>\u5f37\uff0c\u75be\u75c5\u51f6\u96aa\uff0c\u9032\u5c55\u8fc5\u901f\uff0c\u751f\u5b58\u671f\u6975\u77ed\uff0c<\/span><span>R\/R ENKTL<\/span><span>\u60a3\u8005\u7684<\/span><span>1<\/span><span>\u5e74\u751f\u5b58\u7387\u901a\u5e38\u4e0d\u8db3<\/span><span>20%<sup>[2]<\/sup><\/span><span>\u3002\u76ee\u524d\u5728\u4e2d\u570b\u7372\u6279\u7684<\/span><span>\u9776\u5411\u55ae\u85e5\u6cbb\u7642\u5b8c\u5168\u7de9\u89e3\u7387\u7d04\u70ba<\/span><span>6%<sup>[3]<\/sup><\/span><span>\u3002\u4e00\u7dda\u6cbb\u7642\u65b9\u6848\u5931\u6557\u5f8c\u7684\u60a3\u8005\u5b58\u5728\u986f\u8457\u7684\u672a\u88ab\u6eff\u8db3\u7684\u6cbb\u7642\u9700\u6c42\u3002\u540c\u6642\uff0c\u6709<\/span><span>\u7814\u7a76<\/span><sup><span>[4],[5]<\/span><\/sup><span>\u986f\u793a\uff0c\u5118\u7ba1<\/span><span>ENKTL<\/span><span>\u5728\u6771\u4e9e\u548c\u62c9\u4e01\u7f8e\u6d32\u5730\u5340\u767c\u751f\u7387\u76f8\u5c0d\u66f4\u9ad8\uff0c\u4f46\u8a72\u75be\u75c5\u7684\u81e8\u5e8a\u7279\u5fb5\u548c\u6cbb\u7642\u7d50\u679c\u5728\u4e9e\u6d32\u548c\u897f\u65b9\u4eba\u7fa4\u4e2d\u666e\u904d\u76f8\u4f3c\u3002<\/span><\/p>\n<p><b><span>\u95dc\u65bc\u57fa\u77f3\u85e5\u696d<\/span><\/b><\/p>\n<p><span>\u57fa\u77f3\u85e5\u696d\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u4ee3\u78bc<\/span><span>: 2616<\/span><span>\uff09\u662f\u4e00\u5bb6\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc<\/span><span>\u7814\u7a76\u958b\u767c\u53ca\u5546\u696d\u5316\u5275\u65b0\u816b\u7624\u514d\u75ab\u6cbb\u7642\u53ca\u7cbe\u6e96\u6cbb\u7642\u85e5\u7269\uff0c\u4ee5\u6eff\u8db3\u4e2d\u570b\u548c\u5168\u7403\u764c\u75c7\u60a3\u8005\u7684\u6bb7\u5207\u91ab\u7642\u9700\u6c42\u3002\u6210\u7acb\u65bc<\/span><span>2015<\/span><span>\u5e74\u5e95\uff0c\u57fa\u77f3\u85e5\u696d\u5df2\u96c6\u7d50\u4e86\u4e00\u652f\u5728\u65b0\u85e5<\/span><span>\u7814\u767c\u3001\u81e8\u5e8a\u7814\u7a76\u4ee5\u53ca\u5546\u696d\u904b\u71df\u65b9\u9762\u64c1\u6709\u8c50\u5bcc\u7d93\u9a57\u7684\u7ba1\u7406\u5718\u968a\u3002\u516c\u53f8\u4ee5\u816b\u7624\u514d\u75ab\u6cbb\u7642\u806f\u5408\u7642\u6cd5\u70ba\u6838\u5fc3\uff0c\u5efa\u7acb\u4e86\u4e00\u689d<\/span><span>14<\/span><span>\u7a2e\u816b\u7624\u5019\u9078\u85e5\u7269\u7d44\u6210\u7684<\/span><span>\u8c50\u5bcc\u7522\u54c1\u7ba1\u7dda\u3002\u76ee\u524d\uff0c\u57fa\u77f3\u85e5\u696d\u5df2\u7d93\u7372\u5f97\u4e86\u56db\u6b3e\u5275\u65b0\u85e5\u7684<\/span><span>12<\/span><span>\u9805\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u6279\u51c6\u3002\u591a\u6b3e\u5f8c\u671f\u5019\u9078\u85e5\u7269\u6b63\u8655\u65bc\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u6216\u8a3b\u518a\u968e\u6bb5\u3002\u57fa\u77f3\u85e5\u696d\u7684\u9858\u666f\u662f\u6210<\/span><span>\u70ba\u4eab\u8b7d\u5168\u7403\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\uff0c\u5f15\u9818\u653b\u514b\u764c\u75c7\u4e4b\u8def<\/span><span>\u3002<\/span><\/p>\n<p><span>\u5982\u9700\u77ad\u89e3\u6709\u95dc\u57fa\u77f3\u85e5\u696d\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8acb\u8a2a\u554f\uff1a<\/span><span><a href=\"http:\/\/www.cstonepharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.cstonepharma.com<\/a><\/span><span>\u3002<\/span><\/p>\n<p><b><span>\u524d\u77bb\u6027\u8072\u660e<\/span><\/b><\/p>\n<p><span>\u672c\u6587\u6240\u4f5c\u51fa\u7684\u524d\u77bb\u6027\u9673\u8ff0\u50c5\u8207\u672c\u6587\u4f5c\u51fa\u8a72\u9673\u8ff0\u7576\u65e5\u7684\u4e8b\u4ef6\u6216\u8cc7\u6599\u6709\u95dc\u3002\u9664\u6cd5\u5f8b\u898f\u5b9a\u5916\uff0c\u65bc\u4f5c\u51fa\u524d\u77bb\u6027\u9673\u8ff0\u7576\u65e5\u4e4b\u5f8c\uff0c\u7121\u8ad6\u662f\u5426\u51fa\u73fe\u65b0\u8cc7\u6599\u3001\u672a\u4f86\u4e8b\u4ef6\u6216\u5176\u4ed6\u60c5\u6cc1\uff0c\u6211\u5011\u4e26\u7121\u8cac\u4efb\u66f4\u65b0\u6216\u516c\u958b\u4fee\u6539\u4efb\u4f55\u524d\u77bb\u6027\u9673\u8ff0\u53ca\u9810\u6599\u4e4b\u5916\u7684\u4e8b\u4ef6\u3002\u8acb\u7d30\u95b1\u672c\u6587\uff0c\u4e26\u7406\u89e3\u6211\u5011\u7684\u5be6\u969b\u672a\u4f86\u696d\u7e3e\u6216\u8868\u73fe\u53ef\u80fd\u8207\u9810\u671f\u6709\u91cd\u5927\u5dee\u7570\u3002\u672c\u6587\u5167\u6240\u6709\u9673\u8ff0\u4e43\u672c\u6587\u7ae0\u520a\u767c\u65e5\u671f\u4f5c\u51fa\uff0c\u53ef\u80fd\u56e0\u672a\u4f86\u767c\u5c55\u800c\u51fa\u73fe\u8b8a\u52d5\u3002<\/span><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup><span class=\"prnews_span\">[1]\u00a0<\/span><\/sup>\u674e\u5c0f\u79cb\u7b49. &#8220;\u4e2d\u570b\u6dcb\u5df4\u7624\u4e9e\u578b\u5206\u4f48:\u570b\u5167\u591a\u4e2d\u5fc3\u6027\u75c5\u4f8b10002\u4f8b\u5206\u6790.&#8221; \u8a3a\u65b7\u5b78\u7406\u8ad6\u8207\u5be6\u8e10 11.2(2012):5.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup><span class=\"prnews_span\">[2]\u00a0<\/span><\/sup>Bellei M, et al. Haematologica 2018; 103(7): 1191-7.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup><span class=\"prnews_span\">[3]\u00a0<\/span><\/sup>Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup><span class=\"prnews_span\">[4]\u00a0<\/span><\/sup>Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup><span class=\"prnews_span\">[5]\u00a0<\/span><\/sup>Qi S, et al. Leuk Lymphoma 2016;57:2575-83.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><span>\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u64c7\u6377\u7f8e\u00ae\u662f\u5168\u7403\u9996\u500b\u91dd\u5c0d\u5fa9\u767c\u6216\u96e3&#8230;<\/p>\n","protected":false},"author":16,"featured_media":199219,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-188377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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ENKTL\u60a3\u8005\u4e2d\u80fd\u5c55\u73fe\u51fa\u512a\u7570\u7684\u6297\u816b\u7624\u6d3b\u6027\u3001\u6301\u4e45\u7684\u816b\u7624\u7de9\u89e3\u548c\u826f\u597d\u7684\u5b89\u5168\u6027\u3002\u96a8\u8457\u8a72\u9805\u9069\u61c9\u75c7\u7684\u7372\u6279\uff0c\u6211\u5011\u671f\u5f85\u66f4\u591aR\/R ENKTL\u60a3\u8005\u80fd\u65e9\u65e5\u7528\u4e0a\u64c7\u6377\u7f8e\u00ae\u3002\u300d \u64c7\u6377\u7f8e\u00ae\u6b64\u6b21\u9069\u61c9\u75c7\u7684\u7372\u6279\u662f\u57fa\u65bcGEMSTONE-201\u7814\u7a76\uff0c\u8a72\u7814\u7a76\u65e8\u5728\u8a55\u4f30\u64c7\u6377\u7f8e\u00ae\u4f5c\u70ba\u55ae\u85e5\u6cbb\u7642\u6210\u4ebaR\/R 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\u00a0\u674e\u5c0f\u79cb\u7b49. &quot;\u4e2d\u570b\u6dcb\u5df4\u7624\u4e9e\u578b\u5206\u4f48:\u570b\u5167\u591a\u4e2d\u5fc3\u6027\u75c5\u4f8b10002\u4f8b\u5206\u6790.&quot; \u8a3a\u65b7\u5b78\u7406\u8ad6\u8207\u5be6\u8e10 11.2(2012):5.   \u00a0Bellei M, et al. Haematologica 2018; 103(7): 1191-7.   \u00a0Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71.   \u00a0Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27.   \u00a0Qi S, et al. Leuk Lymphoma 2016;57:2575-83.    \u00a0 \u00a0 \u00a0 \u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=188377\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u57fa\u77f3\u85e5\u696d\u5ba3\u4f48\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff09\u6cbb\u7642\u5fa9\u767c\u96e3\u6cbb\u6027\u7d50\u5916NK\/T\u7d30\u80de\u6dcb\u5df4\u7624\u7684\u65b0\u9069\u61c9\u75c7\u5728\u4e2d\u570b\u7372\u6279 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u64c7\u6377\u7f8e\u00ae\u662f\u5168\u7403\u9996\u500b\u91dd\u5c0d\u5fa9\u767c\u6216\u96e3\u6cbb\u6027\u7d50\u5916NK\/T\u7d30\u80de\u6dcb\u5df4\u7624\uff08R\/R 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Haematologica 2018; 103(7): 1191-7.   \u00a0Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71.   \u00a0Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27.   \u00a0Qi S, et al. 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Haematologica 2018; 103(7): 1191-7. \u00a0Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71. \u00a0Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27. \u00a0Qi S, et al. 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Haematologica 2018; 103(7): 1191-7.   \u00a0Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71.   \u00a0Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27.   \u00a0Qi S, et al. 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Haematologica 2018; 103(7): 1191-7.   \u00a0Shi Y, et al. Ann Oncol 2015; 26(8): 1766-71.   \u00a0Haverkos BM, et al. Curr Hematol Malig Rep 2016;11:514-27.   \u00a0Qi S, et al. 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ENKTL\u60a3\u8005\u4e2d\u8010\u53d7\u6027\u548c\u5b89\u5168\u6027\u826f\u597d\uff0c\u672a\u767c\u73fe\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u865f\u3002\u8a72\u7814\u7a76\u7684\u4e3b\u8981\u7d50\u679c\u66fe\u57282022\u5e746\u6708\u7684\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u5b78\u6703\uff08ASCO\uff09\u5e74\u6703\u4e0a\u4ee5\u53e3\u982d\u532f\u5831\u5f62\u5f0f\u516c\u4f48\uff0c\u4e26\u65bc2023\u5e743\u6708\u5728\u570b\u969b\u77e5\u540d\u7684\u816b\u7624\u5b78\u6b0a\u5a01\u671f\u520a\u300aJournal of Clinical Oncology\u300b\uff08JCO\uff09\u5168\u6587\u767c\u8868\u3002 \u95dc\u65bc\u64c7\u6377\u7f8e\u00ae\uff08\u8212\u683c\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff09 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