{"id":39484,"date":"2026-04-16T10:25:55","date_gmt":"2026-04-16T02:25:55","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39484"},"modified":"2026-04-16T10:26:15","modified_gmt":"2026-04-16T02:26:15","slug":"%e8%83%86%e7%ae%a1%e7%99%8c%e5%9c%a8%e7%a0%94%e6%96%b0%e8%8d%af%e8%8e%b7fda%e4%bc%98%e5%85%88%e5%ae%a1%e8%af%84-%e5%85%b3%e9%94%ae%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae%e5%85%ac%e5%b8%83","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/%e8%83%86%e7%ae%a1%e7%99%8c%e5%9c%a8%e7%a0%94%e6%96%b0%e8%8d%af%e8%8e%b7fda%e4%bc%98%e5%85%88%e5%ae%a1%e8%af%84-%e5%85%b3%e9%94%ae%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae%e5%85%ac%e5%b8%83\/","title":{"rendered":"\u80c6\u7ba1\u764c\u5728\u7814\u65b0\u836f\u83b7FDA\u4f18\u5148\u5ba1\u8bc4 \u5173\u952e\u4e34\u5e8a\u6570\u636e\u516c\u5e03"},"content":{"rendered":"\n

\u8fd1\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u63a5\u53d7\u5e76\u6388\u4e88Lirafugratinib\u7684\u65b0\u836f\u7533\u8bf7\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c<\/strong>\uff0c\u8be5\u7533\u8bf7\u65e8\u5728\u9488\u5bf9\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u4f53\u5185\u5b58\u5728FGFR2\u878d\u5408\u6216\u91cd\u6392\u7684\u60a3\u8005\uff0c\u4f5c\u4e3a\u5176\u4e8c\u7ebf\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

FDA\u5df2\u5c06\u5904\u65b9\u836f\u7528\u6237\u8d39\u7528\u6cd5\u6848\uff08PDUFA\uff09\u76ee\u6807\u884c\u52a8\u65e5\u671f\u5b9a\u4e3a2026\u5e749\u670827\u65e5\uff0c\u610f\u5473\u7740FDA\u9884\u8ba1\u57282026\u5e749\u670827\u65e5\u505a\u51fa\u5ba1\u6279\u51b3\u5b9a\u3002<\/strong><\/p>\n\n\n\n

\u6839\u636eFDA\u89c4\u5b9a\uff0c\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u6388\u4e88\u90a3\u4e9b\u82e5\u83b7\u6279\u51c6\uff0c\u5c06\u5bf9\u4e25\u91cd\u75be\u75c5\u7684\u6cbb\u7597\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u5e26\u6765\u663e\u8457\u6539\u5584\u7684\u836f\u7269\u7533\u8bf7\u3002\u80c6\u7ba1\u764c\u4f5c\u4e3a\u4e00\u79cd\u76f8\u5bf9\u5e38\u89c1\u7684\u6076\u6027\u80bf\u7624\uff0c\u5176\u53d1\u75c5\u7387\u591a\u5e74\u6765\u59cb\u7ec8\u7ef4\u6301\u5728\u4e00\u4e2a\u8f83\u9ad8\u7684\u6c34\u5e73\u3002\u9057\u61be\u7684\u662f\uff0c\u7531\u4e8e\u80c6\u7ba1\u764c\u5728\u65e9\u671f\u9636\u6bb5\u7684\u75c7\u72b6\u5f80\u5f80\u8f83\u4e3a\u9690\u533f\uff0c\u5bfc\u81f4\u5927\u591a\u6570\u60a3\u8005\u5728\u786e\u8bca\u65f6\u5df2\u7ecf\u5904\u4e8e\u4e2d\u665a\u671f\uff0c\u8fdb\u800c\u5f71\u54cd\u4e86\u5176\u9884\u540e\u6548\u679c\u3002<\/p>\n\n\n\n

1. <\/strong>\u4f18\u5148\u5ba1\u8bc4\u4f9d\u636e<\/strong><\/p>\n\n\n\n

Lirafugratinib\u65b0\u836f\u7533\u8bf7\u7684\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u57fa\u4e8e1\/2\u671fReFocus\u8bd5\u9a8c<\/strong>\u7684\u79ef\u6781\u4e34\u5e8a\u6570\u636e\u3002\u8be5\u8bd5\u9a8c\u663e\u793a\uff0c\u5728\u62df\u9002\u5e94\u75c7\u60a3\u8005\uff08\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u3001\u643a\u5e26FGFR2\u878d\u5408\u6216\u91cd\u6392\u7684\u80c6\u7ba1\u764c\u60a3\u8005\uff09\u4e2d\uff1a<\/strong><\/p>\n\n\n\n

\u00b7 <\/strong>\u786e\u8ba4\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a46.5%<\/strong>\uff0c\u5373\u670946.5%\u7684\u60a3\u8005\u80bf\u7624\u663e\u8457\u7f29\u5c0f\u6216\u5b8c\u5168\u6d88\u5931\u3002<\/p>\n\n\n\n

\u00b7 <\/strong>\u6700\u4f73\u5ba2\u89c2\u7f13\u89e3\u5305\u62ec\u5b8c\u5168\u7f13\u89e3\u73872.6%\uff0c<\/strong>\u5373\u67092.6%\u7684\u60a3\u8005\u80bf\u7624\u5b8c\u5168\u6d88\u5931\uff1b\u90e8\u5206\u7f13\u89e3\u738743.9%\uff0c<\/strong>\u5373\u670943.9%\u7684\u60a3\u8005\u80bf\u7624\u663e\u8457\u7f29\u5c0f\uff1b\u75be\u75c5\u7a33\u5b9a\u738750.0%\u3002<\/p>\n\n\n\n

\u00b7 <\/strong>\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u4e3a96.5%\u3002<\/strong><\/strong><\/p>\n\n\n\n

\u00b7 <\/strong>\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u4e3a11.8\u4e2a\u6708\uff0c<\/strong>\u5373\u5728\u5bf9\u6cbb\u7597\u6709\u53cd\u5e94\u7684\u60a3\u8005\u4e2d\uff0c\u4e00\u534a\u60a3\u8005\u7597\u6548\u80fd\u7ef4\u6301\u8d85\u8fc711.8\u4e2a\u6708\u3002<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e2d\u4f4d\u65e0<\/strong>\u6076\u5316\u5b58\u6d3b<\/strong>\u671f\uff08PFS\uff09\u4e3a11.3\u4e2a\u6708\uff0c<\/strong>\u5373\u4e00\u534a\u60a3\u8005\u572811.3\u4e2a\u6708\u5185\u75c5\u60c5\u6ca1\u6709\u6076\u5316\u3002<\/p>\n\n\n\n

\u00b7 <\/strong>\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\u4e3a22.8\u4e2a\u6708\uff0c<\/strong>\u5373\u4e00\u534a\u60a3\u8005\u751f\u5b58\u65f6\u95f4\u8d85\u8fc722.8\u4e2a\u6708\u3002<\/p>\n\n\n\n

2. <\/strong>\u5173\u4e8eLirafugratinib<\/strong><\/strong><\/p>\n\n\n\n

Lirafugratinib\u662f\u4e00\u79cd\u5f3a\u6548\u3001\u9009\u62e9\u6027\u3001\u53e3\u670d\u7684\u5c0f\u5206\u5b50FGFR2\u6291\u5236\u5242\uff0c\u7528\u4e8e\u643a\u5e26FGFR2\u6539\u53d8\u7684\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\u60a3\u8005\u3002<\/strong><\/p>\n\n\n\n

FGFR2\u662f\u4e00\u79cd\u53d7\u4f53\u916a\u6c28\u9178\u6fc0\u9176\uff0c\u5728\u67d0\u4e9b\u764c\u75c7\u4e2d\u5e38\u51fa\u73b0\u53d8\u5f02\u3002FGFR2\u662fFGFR\u5bb6\u65cf\u7684\u56db\u4e2a\u6210\u5458\u4e4b\u4e00\uff0c\u8fd9\u4e2a\u5bb6\u65cf\u7684\u86cb\u767d\u8d28\u5e8f\u5217\u548c\u7279\u6027\u9ad8\u5ea6\u76f8\u4f3c\u3002\u5728\u4e34\u5e8a\u524d\u7814\u7a76\u4e2d\uff0cLirafugratinib\u663e\u793a\u51fa\u5bf9FGFR2\u4f9d\u8d56\u6027\u764c\u7ec6\u80de\u7684\u6740\u4f24\u4f5c\u7528\uff0c\u5e76\u5728\u4f53\u5185\u6a21\u578b\u4e2d\u8bf1\u5bfc\u80bf\u7624\u9000\u7f29\uff0c\u540c\u65f6\u5bf9\u5176\u4ed6\u9776\u70b9\uff08\u5305\u62ecFGFR\u5bb6\u65cf\u5176\u4ed6\u6210\u5458\uff09\u7684\u6291\u5236\u6781\u5c0f\u3002\u6b64\u5916\uff0cLirafugratinib\u5728\u4f53\u5916\u548c\u4f53\u5185\u4e34\u5e8a\u524d\u6a21\u578b\u4e2d\uff0c\u5bf9\u5df2\u77e5\u7684\u4e34\u5e8a\u9776\u5411\u8010\u836f\u7a81\u53d8\u8868\u73b0\u51fa\u5f3a\u6548\u6d3b\u6027\u3002<\/p>\n\n\n\n

\u76ee\u524d\uff0cLirafugratinib\u6b63\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u8bc4\u4f30\uff0c\u4ee5\u62db\u52df\u66f4\u591a\u65e2\u5f80\u6cbb\u7597\u8fc7\u7684\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u80c6\u7ba1\u764c\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u4f53\u5185\u5b58\u5728FGFR2\u878d\u5408\u6216\u91cd\u6392\uff0c\u4e14\u5148\u524d\u672a\u63a5\u53d7\u8fc7FGFR\u6291\u5236\u5242\u6cbb\u7597\u3002<\/p>\n\n\n\n

3. <\/strong>\u5173\u4e8eReFocus\u8bd5\u9a8c<\/strong><\/strong><\/p>\n\n\n\n

ReFocus\u8bd5\u9a8c\u662f\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u3001\u9996\u6b21\u9762\u5411\u4eba\u4f53\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u8bd5\u9a8c\u5305\u62ec\u5242\u91cf\u9012\u589e\uff08\u7b2c1\u90e8\u5206\uff09\u3001\u5242\u91cf\u6269\u5c55\uff08\u7b2c2\u90e8\u5206\uff09\u3001\u5ef6\u4f38\uff08\u7b2c3\u90e8\u5206\uff09\u548c\u5ef6\u7eed\uff08\u7b2c4\u90e8\u5206\uff09\u9636\u6bb5\u3002<\/p>\n\n\n\n

\u56db\u4e2a\u9636\u6bb5\u4e2d\u7b26\u5408\u6761\u4ef6\u7684\u60a3\u8005\u81f3\u5c1118\u5c81\uff0c\u75c5\u7406\u6216\u7ec6\u80de\u5b66\u8bc1\u5b9e\u65e0\u6cd5\u624b\u672f\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u7624\uff0c\u5e76\u6709\u5df2\u8bb0\u5f55\u7684FGFR2\u878d\u5408\u3001\u7a81\u53d8\u6216\u6269\u589e\uff0c\u7b26\u5408RECIST 1.1\u6807\u51c6\u7684\u53ef\u6d4b\u91cf\u75c5\u7076\uff0cECOG\u4f53\u80fd\u72b6\u6001\u4e3a0\u62161\u3002\u60a3\u8005\u8fd8\u5fc5\u987b\u4e3a\u6807\u51c6\u6cbb\u7597\u65e0\u6548\u6216\u53cd\u5e94\u4e0d\u4f73\uff0c\u6216\u8005\u6ca1\u6709\u53ef\u7528\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u3002<\/p>\n\n\n\n

\u7b2c1\u90e8\u5206\u4e2d\uff0c\u60a3\u8005\u63a5\u53d7\u53e3\u670dLirafugratinib\u5242\u91cf\u9012\u589e\uff0c\u4ee5\u786e\u5b9a\u63a8\u83502\u671f\u5242\u91cf\uff08RP2D\uff09\u3002<\/p>\n\n\n\n

\u7b2c2\u90e8\u5206\u4e2d\uff0c\u80c6\u7ba1\u764c\u60a3\u8005\u6839\u636eFGFR\u6539\u53d8\u7c7b\u578b\u53ca\u65e2\u5f80\u5316\u7597\u6216FGFR\u6291\u5236\u5242\u66b4\u9732\u60c5\u51b5\u5206\u4e3a4\u4e2a\u961f\u5217\uff0c\u5e76\u6309\u6bcf\u65e5\u6301\u7eed\u7ed9\u836f\u7684\u63a8\u83502\u671f\u5242\u91cf\uff08RP2D\uff09\uff0870 mg\uff09\u63a5\u53d7\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u5173\u952e\u961f\u5217\u7684\u4e3b\u8981\u7ec8\u70b9\u662f\u786e\u8ba4\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u3002\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u3001\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\u3001\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3001\u603b\u751f\u5b58\u671f\uff08OS\uff09\u3001\u5b89\u5168\u6027\u53ca\u751f\u6d3b\u8d28\u91cf\uff08QOL\uff09\u3002<\/p>\n\n\n\n

4. <\/strong>Lirafugratinib\u7684\u5b89\u5168\u6027<\/strong><\/strong><\/p>\n\n\n\n

Lirafugratinib\u663e\u793a\u51fa\u53ef\u9884\u6d4b\u4e14\u53ef\u7ba1\u7406\u7684\u5b89\u5168\u6027\uff0c\u901a\u8fc7\u5242\u91cf\u8c03\u6574\u53ef\u7f13\u89e3\u4e0d\u826f\u53cd\u5e94\u3002<\/p>\n\n\n\n

\u5728ReFocus\u8bd5\u9a8c\u5173\u952e\u5b89\u5168\u6027\u4eba\u7fa4\u4e2d\uff0c\u6700\u5e38\u89c1\u7684\u4efb\u4f55\u7ea7\u522b\u53ca3\u7ea7\uff08\u4e25\u91cd\uff09\u53ca\u4ee5\u4e0a\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u4e3a\u6307\u7532\u6bd2\u6027\uff08\u53d1\u751f\u738787.9%\uff1b12.1%\uff09\u3001\u624b\u8db3\u7ea2\u6591\uff0881.9%\uff1b32.8%\uff09\u3001\u53e3\u8154\u708e\uff0878.4%\uff1b12.1%\uff09\u4ee5\u53ca\u89c6\u7f51\u819c\u8272\u7d20\u4e0a\u76ae\u8131\u79bb\uff0837.1%\uff1b1.7%\uff09\u3002\u5bfc\u81f4\u5242\u91cf\u51cf\u5c11\u3001\u5242\u91cf\u4e2d\u65ad\u53ca\u6cbb\u7597\u505c\u6b62\u7684\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u5206\u522b\u53d1\u751f\u572875.9%\u300182.8%\u548c4.3%\u7684\u60a3\u8005\u4e2d\u3002<\/p>\n\n\n\n

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

\u8fd1\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u63a5\u53d7\u5e76\u6388\u4e88Lirafugratinib\u7684\u65b0\u836f\u7533\u8bf7\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u8be5\u7533\u8bf7\u65e8<\/p>\n","protected":false},"author":14,"featured_media":39478,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1769,6650],"tags":[],"yst_prominent_words":[],"class_list":["post-39484","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-treatment-zh-hans","category-holangiocarcinoma-zh-hans"],"_links":{"self":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39484","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/comments?post=39484"}],"version-history":[{"count":2,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39484\/revisions"}],"predecessor-version":[{"id":39492,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39484\/revisions\/39492"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media\/39478"}],"wp:attachment":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media?parent=39484"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/categories?post=39484"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/tags?post=39484"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/yst_prominent_words?post=39484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}