{"id":41155,"date":"2026-07-23T17:36:30","date_gmt":"2026-07-23T09:36:30","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=41155"},"modified":"2026-07-23T17:36:57","modified_gmt":"2026-07-23T09:36:57","slug":"fda%e6%9c%80%e6%96%b0%e8%8e%b7%e6%89%b9%ef%bd%9cgedatolisib%e4%b8%bapik3ca%e9%87%8e%e7%94%9f%e5%9e%8b%e6%99%9a%e6%9c%9f%e4%b9%b3%e8%85%ba%e7%99%8c%e6%8f%90%e4%be%9b%e5%8f%8c%e8%81%94-%e4%b8%89","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda%e6%9c%80%e6%96%b0%e8%8e%b7%e6%89%b9%ef%bd%9cgedatolisib%e4%b8%bapik3ca%e9%87%8e%e7%94%9f%e5%9e%8b%e6%99%9a%e6%9c%9f%e4%b9%b3%e8%85%ba%e7%99%8c%e6%8f%90%e4%be%9b%e5%8f%8c%e8%81%94-%e4%b8%89\/","title":{"rendered":"FDA\u6700\u65b0\u83b7\u6279\uff5cGedatolisib\u4e3aPIK3CA\u91ce\u751f\u578b\u665a\u671f\u4e73\u817a\u764c\u63d0\u4f9b\u53cc\u8054\/\u4e09\u8054\u65b9\u6848"},"content":{"rendered":"\n<p>HR+\/HER2- \u662f\u665a\u671f\u4e73\u817a\u764c\u6700\u5e38\u89c1\u4e9a\u578b\uff0c\u65e2\u5f80\u4e0a\u5e02PI3K\u6291\u5236\u5242\u4ec5\u9002\u7528\u4e8e\u643a\u5e26PIK3CA\u57fa\u56e0\u7a81\u53d8\u7684\u60a3\u8005\u3002\u7ea6\u516d\u6210\u8be5\u4e9a\u578b\u60a3\u8005\u4e3aPIK3CA\u91ce\u751f\u578b\uff0c\u957f\u671f\u7f3a\u5c11\u83b7\u6279\u7684PI3K\/mTOR\u901a\u8def\u9776\u5411\u836f\u7269\u30022026\u5e747\u670814\u65e5\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u5409\u8fbe\u5229\u585e\uff08gedatolisib\uff09\u4e0a\u5e02\uff0c\u4e3a\u8fd9\u7c7b\u7ecf\u5185\u5206\u6ccc\u6cbb\u7597\u8fdb\u5c55\u540e\u7684\u60a3\u8005\u63d0\u4f9b\u5168\u65b0\u8054\u5408\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n<p>***\u672c\u836f\u7269\u76ee\u524d\u5c1a\u672a\u5728\u9999\u6e2f\u53ca\u4e2d\u56fd\u5927\u9646\u83b7\u5f97\u4e0a\u5e02\u6279\u51c6\u3002\u6709\u76f8\u5173\u6cbb\u7597\u9700\u6c42\u7684\u60a3\u8005\uff0c\u5728\u7ecf\u533b\u751f\u9762\u8bca\u8bc4\u4f30\u540e\uff0c\u53ef\u901a\u8fc7\u9999\u6e2f\u201c \u6307\u5b9a\u836f\u7269\u4f7f\u7528\u8ba1\u5212\uff08NPA\uff09 \u201d\u7533\u8bf7\u76f8\u5173\u6cbb\u7597\u7528\u836f\uff0c\u6709\u9700\u8981\u5373\u53ef\u8054\u7cfb\u6211\u4eec\u9999\u6e2f\u7efc\u5408\u80bf\u7624\u4e2d\u5fc3\u7684\u5ba2\u670d\u67e5\u8be2\u4e86\u89e3\u66f4\u591a\u3002<\/p>\n\n\n\n<p>* Name Patient Access Program\uff08\u5373NPA\uff09\u201c\u6307\u5b9a\u836f\u7269\u4f7f\u7528\u8ba1\u5212\u201d\uff0c\u4fd7\u79f0\u201c\u65b0\u836f\u7eff\u8272\u901a\u9053\u201d\uff0c\u7b26\u5408\u4ee5\u4e0b\u4e24\u4e2a\u60c5\u51b5\u7684\u75c5\u4eba\uff0c\u53ef\u4ee5\u900f\u8fc7NPA\u4f7f\u7528\u8fd9\u4e9b\u521b\u65b0\u764c\u75c7\u836f\u7269\uff1a&nbsp; &nbsp;<\/p>\n\n\n\n<p>1. \u75c5\u4eba\u9700\u8981\u7684\u521b\u65b0\u836f\u7269\u5728\u9999\u6e2f\u4ecd\u672a\u6ce8\u518c\uff0c\u4f46\u5728\u6b27\u7f8e\u6216\u5185\u5730\u5df2\u4e0a\u5e02\u3002&nbsp; &nbsp;<\/p>\n\n\n\n<p>2. \u5fc5\u987b\u7ecf\u9999\u6e2f\u7684\u533b\u751f\uff08\u4e3b\u8981\u662f\u4e34\u5e8a\/\u5185\u79d1\u80bf\u7624\u79d1\u4e13\u79d1\u533b\u751f\uff09\u8bca\u65ad\u548c\u8bc4\u4f30\u540e\uff0c\u786e\u5b9a\u75c5\u4eba\u7684\u60c5\u51b5\u9002\u5408\u6216\u6709\u5fc5\u8981\u4f7f\u7528\u8be5\u9879\u521b\u65b0\u836f\u7269\u3002<\/p>\n\n\n\n<p><strong>\u4e00\u3001\u836f\u54c1\u57fa\u7840\u5ba1\u6279\u4fe1\u606f<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>\u00b7 <\/strong>\u83b7\u6279\u673a\u6784\uff1a\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09<\/p>\n\n\n\n<p><strong>\u00b7 <\/strong>\u83b7\u6279\u65e5\u671f\uff1a2026\u5e747\u670814\u65e5<\/p>\n\n\n\n<p><strong>\u00b7 <\/strong>\u901a\u7528\u540d\uff1a\u5409\u8fbe\u5229\u585e\uff08gedatolisib\uff09<\/p>\n\n\n\n<p><strong>\u00b7 <\/strong>\u5ba1\u8bc4\u901a\u9053\uff1a\u91c7\u7528FDA\u5b9e\u65f6\u80bf\u7624\u5ba1\u8bc4\uff08RTOR\uff09\u52a0\u901f\u9879\u76ee\u5b8c\u6210\u5ba1\u6279<\/p>\n\n\n\n<p><strong>\u83b7\u6279\u9650\u5b9a\u9002\u5e94\u75c7<\/strong><\/p>\n\n\n\n<p>\u9002\u7528\u4e8e\u6210\u5e74\u5c40\u90e8\u665a\u671f\/\u8f6c\u79fb\u6027 HR+\/HER2- \u4e73\u817a\u764c\u60a3\u8005\uff0c\u9700\u540c\u65f6\u6ee1\u8db3\u4e24\u9879\u6761\u4ef6\uff1a<\/p>\n\n\n\n<p>1. \u80bf\u7624\u672a\u68c0\u51fa PIK3CA \u57fa\u56e0\u7a81\u53d8\uff1b<\/p>\n\n\n\n<p>2. \u65e2\u5f80\u5728\u665a\u671f\u9636\u6bb5\u63a5\u53d7\u81f3\u5c11\u4e00\u7ebf\u5185\u5206\u6ccc\u6cbb\u7597\u540e\u53d1\u751f\u75be\u75c5\u8fdb\u5c55\u3002<\/p>\n\n\n\n<p><strong>\u4e34\u5e8a\u53ef\u9009\u62e9\u4e24\u79cd\u8054\u5408\u65b9\u6848\uff1a<\/strong><strong><\/strong><\/p>\n\n\n\n<p>1. \u5409\u8fbe\u5229\u585e + \u6c1f\u7ef4\u53f8\u7fa4\uff08\u4e8c\u8054\u65b9\u6848\uff09&nbsp;<\/p>\n\n\n\n<p>2. \u5409\u8fbe\u5229\u585e + \u6c1f\u7ef4\u53f8\u7fa4 + \u54cc\u67cf\u897f\u5229\uff08\u4e09\u8054\u65b9\u6848\uff09<\/p>\n\n\n\n<p><strong>\u4e8c\u3001\u836f\u7269\u4f5c\u7528\u673a\u5236<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u5409\u8fbe\u5229\u585e\u5c5e\u4e8e\u6cdb PI3K\/mTOR\uff08PAM\uff09\u901a\u8def\u6291\u5236\u5242\uff0c\u53ef\u540c\u65f6\u6291\u5236\u5168\u90e84\u79cd\u2160\u7c7b PI3K \u540c\u5de5\u9176\uff0c\u4ee5\u53ca mTORC1\u3001mTORC2 \u590d\u5408\u7269\uff0c\u5b8c\u6574\u963b\u65ad PI3K-AKT-mTOR \u4fc3\u589e\u6b96\u901a\u8def\u3002<\/p>\n\n\n\n<p>\u4f20\u7edf\u9009\u62e9\u6027 PI3K\u03b1 \u6291\u5236\u5242\u4ec5\u963b\u65ad\u5355\u4e00\u4e9a\u578b\u901a\u8def\uff0c\u80bf\u7624\u6613\u901a\u8fc7\u5176\u4ed6 PI3K\u4e9a\u578b\u3001mTOR\u590d\u5408\u4f53\u4ee3\u507f\u6fc0\u6d3b\uff0c\u8fdb\u800c\u4ea7\u751f\u8010\u836f\u3002\u5409\u8fbe\u5229\u585e\u5168\u901a\u8def\u6291\u5236\u7684\u7279\u6027\uff0c\u4f7f\u5176\u5bf9 PIK3CA \u91ce\u751f\u578b\u80bf\u7624\u540c\u6837\u5177\u5907\u6297\u80bf\u7624\u6d3b\u6027\uff0c\u4e5f\u662f\u672c\u6b21\u83b7\u6279\u5bf9\u5e94\u4eba\u7fa4\u7684\u6838\u5fc3\u4f9d\u636e\u3002<\/p>\n\n\n\n<p><strong>\u4e09\u3001\u83b7\u6279\u6838\u5fc3\u4f9d\u636e\uff1a\u2162\u671f VIKTORIA-1\uff08NCT05501886\uff09\u4e34\u5e8a\u8bd5\u9a8c<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>\u8bd5\u9a8c\u8bbe\u8ba1<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u968f\u673a\u5bf9\u7167\u7814\u7a76\uff0c\u5171\u7eb3\u5165392\u4f8b\u4e0d\u53ef\u624b\u672f\u5c40\u90e8\u665a\u671f\/\u8f6c\u79fb\u6027 HR+\/HER2- \u4e73\u817a\u764c\u53d7\u8bd5\u8005\uff0c1:1:1\u5206\u4e3a\u4e09\u7ec4\uff1a<\/p>\n\n\n\n<p><strong>\u00b7 <\/strong><strong>A\u7ec4\uff1a<\/strong>\u5409\u8fbe\u5229\u585e+\u6c1f\u7ef4\u53f8\u7fa4+\u54cc\u67cf\u897f\u5229\uff08\u4e09\u8054\uff09\uff1a A\u7ec4\u4e2d\u4f4dPFS\u8fbe9.3\u4e2a\u6708\uff0895%CI\uff1a7.2\u201316.6\uff09\uff0c\u5bf9\u7167\u7ec4\u4ec52.0\u4e2a\u6708\uff0895%CI\uff1a1.8\u20132.3\uff09\uff0c\u75be\u75c5\u8fdb\u5c55\u98ce\u9669\u5927\u5e45\u4e0b\u964d76%\uff08HR=0.24\uff0cp\uff1c0.0001\uff09\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"692\" height=\"391\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2.png\" alt=\"\" class=\"wp-image-41164 lazyload\" data-srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2-300x170.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><noscript><img decoding=\"async\" width=\"692\" height=\"391\" src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2.png\" alt=\"\" class=\"wp-image-41164 lazyload\" srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-2-300x170.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><\/noscript><figcaption class=\"wp-element-caption\">\u56fe\u6e90\uff1a\u836f\u4f01&nbsp;\u2162\u671f&nbsp;VIKTORIA-1<\/figcaption><\/figure>\n\n\n\n<p><strong>\u00b7 <\/strong><strong>B\u7ec4\uff1a<\/strong>\u5409\u8fbe\u5229\u585e+\u6c1f\u7ef4\u53f8\u7fa4\uff08\u4e8c\u8054\uff09 \uff1aB\u7ec4\u4e2d\u4f4dPFS\u8fbe7.4\u4e2a\u6708\uff0895%CI\uff1a5.5\u20139.9\uff09\uff0c\u663e\u8457\u4f18\u4e8e\u5bf9\u7167\u7ec4\uff0c\u75be\u75c5\u8fdb\u5c55\u98ce\u9669\u4e0b\u964d67%\uff08HR=0.33\uff0cp\uff1c0.0001\uff09\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"692\" height=\"377\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3.png\" alt=\"\" class=\"wp-image-41167 lazyload\" data-srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3-300x163.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><noscript><img decoding=\"async\" width=\"692\" height=\"377\" src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3.png\" alt=\"\" class=\"wp-image-41167 lazyload\" srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-3-300x163.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><\/noscript><figcaption class=\"wp-element-caption\">\u56fe\u6e90\uff1a\u836f\u4f01&nbsp;\u2162\u671f&nbsp;VIKTORIA-1<\/figcaption><\/figure>\n\n\n\n<p><strong>\u00b7 <\/strong><strong>C\u7ec4\uff1a<\/strong>\u6c1f\u7ef4\u53f8\u7fa4\u5355\u836f\uff08\u5bf9\u7167\u7ec4\uff09&nbsp;<\/p>\n\n\n\n<p>\u53d7\u8bd5\u8005\u6301\u7eed\u7528\u836f\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u53ef\u8010\u53d7\u6bd2\u6027\uff1b\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u4e3a\u76f2\u6001\u72ec\u7acb\u8bc4\u5ba1\u59d4\u5458\u4f1a\uff08BICR\uff09\u8bc4\u4f30\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff1b\u6b21\u8981\u7ec8\u70b9\u5305\u542b\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\uff1b\u672c\u6b21\u83b7\u6279\u65f6\u603b\u751f\u5b58\u671f\uff08OS\uff09\u6570\u636e\u5c1a\u672a\u6210\u719f\uff0c\u4ec5 25% \u53d7\u8bd5\u8005\u51fa\u73b0\u6b7b\u4ea1\u4e8b\u4ef6\u3002<\/p>\n\n\n\n<p><strong>\u6838\u5fc3\u7597\u6548\u6570\u636e\uff08RECIST 1.1 \u6807\u51c6\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"693\" height=\"369\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1.png\" alt=\"\" class=\"wp-image-41156 lazyload\" data-srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1.png 693w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1-300x160.png 300w\" sizes=\"(max-width: 693px) 100vw, 693px\" \/><noscript><img decoding=\"async\" width=\"693\" height=\"369\" src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1.png\" alt=\"\" class=\"wp-image-41156 lazyload\" srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1.png 693w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/07\/image-1-300x160.png 300w\" sizes=\"(max-width: 693px) 100vw, 693px\" 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