{"id":39490,"date":"2026-04-16T10:26:00","date_gmt":"2026-04-16T02:26:00","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39490"},"modified":"2026-04-16T11:28:43","modified_gmt":"2026-04-16T03:28:43","slug":"%e9%a6%96%e4%b8%aa%e9%92%88%e5%af%b9%e9%ab%98%e7%ba%a7%e5%88%ab%e8%83%b6%e8%b4%a8%e7%98%a4%e7%9a%84%e9%9d%b6%e5%90%91btd%e8%8d%af%e7%89%a9%ef%bc%9aplixorafenib%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/%e9%a6%96%e4%b8%aa%e9%92%88%e5%af%b9%e9%ab%98%e7%ba%a7%e5%88%ab%e8%83%b6%e8%b4%a8%e7%98%a4%e7%9a%84%e9%9d%b6%e5%90%91btd%e8%8d%af%e7%89%a9%ef%bc%9aplixorafenib%e4%b8%b4%e5%ba%8a%e6%95%b0%e6%8d%ae\/","title":{"rendered":"\u9996\u4e2a\u9488\u5bf9\u9ad8\u7ea7\u522b\u80f6\u8d28\u7624\u7684\u9776\u5411BTD\u836f\u7269\uff1aPlixorafenib\u4e34\u5e8a\u6570\u636e\u89e3\u6790"},"content":{"rendered":"\n

2026\u5e744\u67082\u65e5\uff0cFORE Biotherapeutics \u5ba3\u5e03\uff1a\u7f8e\u56fdFDA\u6b63\u5f0f\u6388\u4e88\u5176\u5728\u7814\u53e3\u670d BRAF \u6291\u5236\u5242 Plixorafenib\uff08FORE8394\uff09\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08BTD\uff09\uff0c\u7528\u4e8e\u6cbb\u7597BRAF V600E \u7a81\u53d8\u7684\u590d\u53d1 \/ \u96be\u6cbb\u6027\u9ad8\u7ea7\u522b\u80f6\u8d28\u7624\uff08HGG\uff09<\/strong>\u3002<\/p>\n\n\n\n

\u8fd9\u662fFDA\u5386\u53f2\u4e0a\u9996\u6b21<\/strong>\u4e3a\u9ad8\u7ea7\u522b\u80f6\u8d28\u7624<\/strong>\u9776\u5411\u7597\u6cd5\u9881\u53d1\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a<\/strong>\uff0c\u6807\u5fd7\u7740\u8fd9\u4e00\u9ad8\u5ea6\u6076\u6027\u8111\u7624\u7684\u7cbe\u51c6\u6cbb\u7597\u53d6\u5f97\u91cc\u7a0b\u7891\u5f0f\u8fdb\u5c55\u3002<\/p>\n\n\n\n

FDA\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08BTD\uff09<\/strong><\/strong><\/p>\n\n\n\n

BTD \u6388\u4e88\u6ee1\u8db3\u4e24\u5927\u6761\u4ef6\u7684\u836f\u7269\uff1a<\/strong><\/strong><\/p>\n\n\n\n

1. \u7528\u4e8e\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u75be\u75c5 
2. \u4e34\u5e8a\u8bc1\u636e\u663e\u793a\u663e\u8457\u4f18\u4e8e\u73b0\u6709\u7597\u6cd5 <\/p>\n\n\n\n

Plixorafenib \u83b7\u5f97 BTD \u540e\u53ef\u4eab\u53d7\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u2022 FDA \u8d44\u6df1\u56e2\u961f\u5168\u7a0b\u6307\u5bfc\u5f00\u53d1 
\u2022 \u6eda\u52a8\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09 
\u2022 \u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff08\u83b7\u6279\u5468\u671f\u5927\u5e45\u7f29\u77ed\uff09 
\u2022 \u52a0\u901f\u4e0a\u5e02\uff0c\u60e0\u53ca\u60a3\u8005<\/p>\n\n\n\n

<\/p>\n\n\n\n

1. <\/strong>\u9ad8\u7ea7\u522b\u80f6\u8d28\u7624\u6cbb\u7597\u56f0\u5883<\/strong><\/strong><\/p>\n\n\n\n

\u9ad8\u7ea7\u522b\u80f6\u8d28\u7624\uff08WHO \u2162~\u2163\u7ea7\uff0c\u542b\u80f6\u8d28\u6bcd\u7ec6\u80de\u7624\u3001\u95f4\u53d8\u6027\u661f\u5f62\u7ec6\u80de\u7624\uff09\u662f\u6700\u5177\u4fb5\u88ad\u6027\u7684\u539f\u53d1\u6027\u8111\u80bf\u7624\uff1a<\/strong>
\u00b7 <\/strong>\u6807\u51c6\u6cbb\u7597\u4e3a\u624b\u672f+\u540c\u6b65\u653e\u5316\u7597+\u66ff\u83ab\u5511\u80fa<\/strong>\uff0c\u4f46\u590d\u53d1\u7387\u6781\u9ad8\u3001\u9884\u540e\u6781\u5dee<\/strong>
\u00b7 <\/strong>\u80f6\u8d28\u6bcd\u7ec6\u80de\u7624\uff08GBM\uff0c\u2163\u7ea7\uff095\u5e74\u751f\u5b58\u7387\u4ec55%~10%<\/strong>
\u00b7 <\/strong>\u4f20\u7edf\u836f\u7269\u96be\u4ee5\u7a7f\u900f\u8840\u8111\u5c4f\u969c<\/strong>\u3001\u7597\u6548\u6709\u9650\u3001\u6bd2\u526f\u4f5c\u7528\u660e\u663e
\u00b7 BRAF V600E\u7a81\u53d8<\/strong>\u5728\u90e8\u5206\u4e9a\u578b\u4e2d\u53d1\u751f\u7387\u7ea610%~20%<\/strong>\uff0c\u957f\u671f\u7f3a\u4e4f\u9488\u5bf9\u6027\u9556\u9776\u836f\u7269<\/p>\n\n\n\n

<\/p>\n\n\n\n

2. <\/strong>Plixorafenib\uff1a\u673a\u5236\u4e0e\u4f18\u52bf<\/strong><\/p>\n\n\n\n

Plixorafenib \u4e3a\u65b0\u4e00\u4ee3\u53e3\u670dBRAF\u6291\u5236\u5242\uff0c\u5177\u5907\u4e24\u5927\u6838\u5fc3\u673a\u5236\uff1a
1. \u53cc\u91cd\u6291\u5236\uff1a<\/strong>\u6291\u5236 BRAF \u4e8c\u805a\u4f53\u6fc0\u6d3b + \u907f\u514d MAPK \u901a\u8def\u201c\u6096\u8bba\u6027\u6fc0\u6d3b\u201d
2. \u8840\u8111\u5c4f\u969c\u7a7f\u900f\u6027\uff1a<\/strong>\u6709\u6548\u8fdb\u5165\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\uff0c\u9488\u5bf9\u8111\u5185\u75c5\u7076
3. \u53e3\u670d\u7ed9\u836f\uff1a<\/strong>\u63d0\u5347\u60a3\u8005\u4f9d\u4ece\u6027\u4e0e\u751f\u6d3b\u8d28\u91cf
4. \u9776\u70b9\u7cbe\u51c6\uff1a<\/strong>\u5bf9 *BRAF V600 \u7a81\u53d8\uff081 \u7c7b\uff09\u53ca BRAF \u878d\u5408\uff082 \u7c7b\uff09* \u5747\u6709\u6548<\/p>\n\n\n\n

<\/p>\n\n\n\n

3. <\/strong>\u6838\u5fc3\u4e34\u5e8a\u6570\u636e<\/strong><\/p>\n\n\n\n

\u5165\u7ec4\u4eba\u7fa4\uff1a<\/strong>BRAF V600 \u7a81\u53d8\u3001\u590d\u53d1 \/ \u96be\u6cbb\u6027\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u80bf\u7624<\/p>\n\n\n\n

\u5173\u952e\u7597\u6548\u6570\u636e\uff1a<\/strong><\/p>\n\n\n\n

\u00b7 \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff0967%<\/strong>\uff089\u4f8b\u672a\u63a5\u53d7\u8fc7 MAPK \u6291\u5236\u5242\u60a3\u8005\uff09
\u2192 67% \u60a3\u8005\u80bf\u7624\u663e\u8457\u7f29\u5c0f\u6216\u5b8c\u5168\u6d88\u5931 <\/p>\n\n\n\n

\u00b7 \u4e34\u5e8a\u83b7\u76ca\u7387\uff08CBR\uff09\uff1e75%<\/strong>
\u2192 \u8d85 75% \u60a3\u8005\u80bf\u7624\u5f97\u5230\u63a7\u5236\uff08\u7f29\u5c0f\u6216\u7a33\u5b9a\uff09 <\/p>\n\n\n\n

\u00b7 \u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08mDOR\uff0917.8\u4e2a\u6708<\/strong>
\u2192 \u6709\u6548\u60a3\u8005\u7597\u6548\u7ef4\u6301\u8d85 17.8\u4e2a\u6708 <\/p>\n\n\n\n

\u00b7 \u836f\u7269\u76f8\u5173\u505c\u836f\u7387\uff1c2%<\/strong>
\u2192 \u5b89\u5168\u6027\u663e\u8457\u4f18\u4e8e\u73b0\u6709 BRAF \u6291\u5236\u5242 <\/p>\n\n\n\n

\u6570\u636e\u5df2\u57282023\u5e74 ASCO\u3001SNO\u5e74\u4f1a\u516c\u5e03\uff0c\u7ecf\u540c\u884c\u8bc4\u8bae\u3002<\/p>\n\n\n\n

<\/p>\n\n\n\n

4. Plixorafenib \u5df2\u83b7FDA\u4e09\u9879\u7279\u6b8a\u8ba4\u5b9a<\/strong><\/p>\n\n\n\n

1. \u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08BTD\uff09\uff1a<\/strong>BRAF V600E \u7a81\u53d8 HGG\uff082026.4\uff09 
2. \u5feb\u901f\u901a\u9053\u8ba4\u5b9a\uff1a<\/strong>\u7ecf\u6cbb BRAF 1\/2 \u7c7b\u7a81\u53d8\u5b9e\u4f53\u7624 
3. \u5b64\u513f\u836f\u8d44\u683c\uff1a<\/strong>\u539f\u53d1\u8111\u53ca\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u6076\u6027\u80bf\u7624<\/p>\n\n\n\n

<\/p>\n\n\n\n

5. \u5c55\u671b\uff1a<\/strong><\/p>\n\n\n\n

Plixorafenib \u51ed\u501f\u9ad8\u7f13\u89e3\u7387\u3001\u957f\u7f13\u89e3\u6301\u7eed\u3001\u4f4e\u6bd2\u6027\u3001\u8840\u8111\u5c4f\u969c\u7a7f\u900f<\/strong>\uff0c\u6709\u671b\u6210\u4e3aBRAF V600E \u7a81\u53d8\u80f6\u8d28\u7624\u9996\u4e2a\u6807\u51c6\u9776\u5411\u65b9\u6848<\/strong>\u30022026\u5e74\u5e95\u5173\u952e\u6570\u636e\u516c\u5e03<\/strong>\u5c06\u51b3\u5b9a\u5176\u80fd\u5426\u52a0\u901f\u83b7\u6279\u4e0a\u5e02\u3002<\/p>\n\n\n\n\u8d44\u6599\u6765\u6e90\uff1ahttps:\/\/www.targetedonc.com\/view\/fda-grants-breakthrough-therapy-designation-to-plixorafenib-for-braf-v600e-glioma<\/a>\n\n\n\n

\u8f6c\u8f7d\u8bf7\u8054\u7cfb\u6388\u6743\uff0c\u6216\u6ce8\u660e\u6765\u6e90<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

2026\u5e744\u67082\u65e5\uff0cFORE Biotherapeutics \u5ba3\u5e03\uff1a\u7f8e\u56fdFDA\u6b63\u5f0f\u6388\u4e88\u5176\u5728\u7814\u53e3\u670d BRAF \u6291<\/p>\n","protected":false},"author":14,"featured_media":39472,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1769,6756],"tags":[],"yst_prominent_words":[],"class_list":["post-39490","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-treatment-zh-hans","category-6756"],"_links":{"self":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39490","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=39490"}],"version-history":[{"count":7,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39490\/revisions"}],"predecessor-version":[{"id":39505,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/39490\/revisions\/39505"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media\/39472"}],"wp:attachment":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media?parent=39490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/categories?post=39490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/tags?post=39490"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/yst_prominent_words?post=39490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}