{"id":39179,"date":"2024-06-25T12:24:00","date_gmt":"2024-06-25T12:24:00","guid":{"rendered":"https:\/\/indogenmed.org\/resource\/fda-approves-inavolisib-with-palbociclib-and-fulvestrant-for-advanced-breast-cancer\/"},"modified":"2026-07-10T09:40:30","modified_gmt":"2026-07-10T09:40:30","slug":"fda-approval-inavolisib-palbociclib-fulvestrant","status":"publish","type":"post","link":"https:\/\/indogenmed.org\/zh-hans\/resource\/fda-approval-inavolisib-palbociclib-fulvestrant\/","title":{"rendered":"FDA \u6279\u51c6 Inavolisib \u8054\u5408 Palbociclib \u548c Fulvestrant \u6cbb\u7597\u665a\u671f\u4e73\u817a\u764c"},"content":{"rendered":"<p>2024\u5e7410\u670810\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6 <a href=\"\/molecule\/ivosidenib\/\" target=\"_blank\" rel=\"noopener\">Inavolisib<\/a> \u8054\u5408 <a href=\"\/molecule\/palbociclib\/\" target=\"_blank\" rel=\"noopener\">Palbociclib<\/a> \u548c Fulvestrant\uff0c\u7528\u4e8e\u6cbb\u7597\u7b26\u5408\u7279\u5b9a\u6807\u51c6\u7684\u6210\u4eba\u665a\u671f\u4e73\u817a\u764c\u3002\u6b64\u9879\u6279\u51c6\u5bf9\u4e8e\u4ee5\u4e0b\u60a3\u8005\u81f3\u5173\u91cd\u8981\uff1a<\/p>\n<ul>\n<li>\u5185\u5206\u6ccc\u6cbb\u7597\u62b5\u6297\u6027\u4e73\u817a\u764c<\/li>\n<li>PIK3CA \u7a81\u53d8\u80bf\u7624<\/li>\n<li>\u6fc0\u7d20\u53d7\u4f53\uff08HR\uff09\u9633\u6027\u72b6\u6001<\/li>\n<li>HER2 \u9634\u6027\u72b6\u6001<\/li>\n<li>\u7ecf FDA \u6279\u51c6\u7684\u68c0\u6d4b\u786e\u5b9a\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u75be\u75c5<\/li>\n<li>\u5b8c\u6210\u65e2\u5f80\u5185\u5206\u6ccc\u6cbb\u7597\u540e\u590d\u53d1<\/li>\n<\/ul>\n<h2><b>\u7814\u7a76\u6982\u8ff0<\/b><\/h2>\n<p>INAVO120 \u7814\u7a76\u662f\u4e00\u9879 III \u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65e8\u5728\u8bc4\u4f30 inavolisib \u8054\u5408 Palbociclib \u548c fulvestrant \u76f8\u5bf9\u4e8e\u5b89\u6170\u5242\u8054\u5408 Palbociclib \u548c fulvestrant \u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u8be5\u7814\u7a76\u91cd\u70b9\u5173\u6ce8 PIK3CA \u7a81\u53d8\u3001\u6fc0\u7d20\u53d7\u4f53\uff08HR\uff09\u9633\u6027\u3001HER2 \u9634\u6027\u3001\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u4e14\u5bf9\u5185\u5206\u6ccc\u6cbb\u7597\u4ea7\u751f\u62b5\u6297\u7684 <a href=\"\/zh-hans\/medicine\/oncology\/\">\u4e73\u817a\u764c<\/a>\u3002\u4ee5\u4e0b\u662f\u8be5\u7814\u7a76\u7684\u4e00\u4e9b\u8981\u70b9\u3002<\/p>\n<p>\u8be5\u7814\u7a76\u5171\u7eb3\u5165 325 \u540d\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u5728\u5b8c\u6210\u5185\u5206\u6ccc\u6cbb\u7597\u540e\u75c5\u60c5\u6076\u5316\u3002<\/p>\n<p>\u60a3\u8005\u88ab\u5206\u4e3a\u4e24\u7ec4\uff1a<\/p>\n<ul>\n<li>\u4e00\u7ec4\u63a5\u53d7 Inavolisib\uff08\u6bcf\u65e5\u4e00\u6b21 9 \u6beb\u514b\uff09\u3001Palbociclib\uff08\u6bcf\u65e5\u4e00\u6b21 125 \u6beb\u514b\uff0c\u670d\u7528 21 \u5929\u540e\u505c\u836f 7 \u5929\uff09\u548c Fulvestrant\uff08\u5728\u7279\u5b9a\u65e5\u671f\u7ed9\u836f 500 \u6beb\u514b\uff09\u3002<\/li>\n<li>\u53e6\u4e00\u7ec4\u63a5\u53d7\u5b89\u6170\u5242\u800c\u975e Inavolisib\u3002<\/li>\n<\/ul>\n<p>\u4e3b\u8981\u7ec8\u70b9\u662f\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff0c\u5b9a\u4e49\u4e3a\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u7684\u65f6\u95f4\u3002<\/p>\n<h2><b>\u7814\u7a76\u7ed3\u679c<\/b><\/h2>\n<ul>\n<li>\u6cbb\u7597\u7ec4\uff08Inavolisib + Palbociclib + Fulvestrant\uff09\u7684\u4e2d\u4f4d PFS \u4e3a 15.0 \u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a 7.3 \u4e2a\u6708\u3002<\/li>\n<li>\u6cbb\u7597\u7ec4\u7684\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a 58%\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4ec5\u4e3a 25%\u3002<\/li>\n<li>\u6cbb\u7597\u7ec4\u7684\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u4e3a 18.4 \u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u4e3a 9.6 \u4e2a\u6708\u3002<\/li>\n<\/ul>\n<h2><b>\u5e38\u89c1\u526f\u4f5c\u7528<\/b><\/h2>\n<p>\u63a5\u53d7\u8fd9\u79cd\u8054\u5408\u6cbb\u7597\u7684\u60a3\u8005\u51fa\u73b0\u4e86\u4e00\u4e9b\u526f\u4f5c\u7528\u3002\u6700\u5e38\u89c1\u7684\u5f71\u54cd\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff08\u4e00\u79cd\u767d\u7ec6\u80de\uff09<\/li>\n<li>\u8840\u7ea2\u86cb\u767d\u964d\u4f4e\uff08\u53ef\u80fd\u5bfc\u81f4\u8d2b\u8840\uff09<\/li>\n<li>\u7a7a\u8179\u8840\u7cd6\u5347\u9ad8<\/li>\n<li>\u53e3\u8154\u708e\uff08\u53e3\u8154\u708e\u75c7\uff09<\/li>\n<li>\u8179\u6cfb<\/li>\n<li>\u75b2\u52b3<\/li>\n<\/ul>\n<h2><b>\u4f34\u968f\u8bca\u65ad\u8bbe\u5907\u83b7\u6279<\/b><\/h2>\n<p>FoundationOne Liquid CDx \u68c0\u6d4b\u88ab\u6279\u51c6\u4f5c\u4e3a\u4f34\u968f\u8bca\u65ad\u5de5\u5177\u3002\u8be5\u68c0\u6d4b\u6709\u52a9\u4e8e\u8bc6\u522b\u53ef\u80fd\u4ece Inavolisib\u3001Palbociclib \u548c Fulvestrant \u6cbb\u7597\u4e2d\u83b7\u76ca\u7684\u4e73\u817a\u764c\u60a3\u8005\u3002<\/p>\n<h2><b>\u5feb\u901f\u5ba1\u6279<\/b><\/h2>\n<p>\u6b64\u9879\u6279\u51c6\u662f\u201c\u5965\u6bd4\u65af\u9879\u76ee\u201d\uff08Project Orbis\uff09\u7684\u4e00\u90e8\u5206\uff0c\u8be5\u9879\u76ee\u5141\u8bb8\u591a\u4e2a\u56fd\u5bb6\u540c\u65f6\u5ba1\u67e5\u6297\u764c\u836f\u7269\u3002FDA \u4e0e\u6fb3\u5927\u5229\u4e9a\u3001\u52a0\u62ff\u5927\u548c\u745e\u58eb\u7684\u536b\u751f\u5f53\u5c40\u8fdb\u884c\u4e86\u5408\u4f5c\u3002\u8be5\u7533\u8bf7\u83b7\u5f97\u4e86\u4f18\u5148\u5ba1\u67e5\u548c\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff0c\u4f7f\u5f97\u5ba1\u6279\u6bd4\u9884\u671f\u63d0\u524d\u4e86\u4e03\u5468\u3002<\/p>\n<h2><b>\u5173\u4e8e\u6fc0\u7d20\u53d7\u4f53\u9633\u6027\u4e73\u817a\u764c<\/b><\/h2>\n<h3>\u4ec0\u4e48\u662f HR \u9633\u6027\u4e73\u817a\u764c\uff1f<\/h3>\n<ul>\n<li>\u8fd9\u79cd\u7c7b\u578b\u7684\u4e73\u817a\u764c\u7ea6\u5360\u6240\u6709\u4e73\u817a\u764c\u75c5\u4f8b\u7684 70%\u3002<\/li>\n<li>\u80bf\u7624\u7ec6\u80de\u5177\u6709\u96cc\u6fc0\u7d20\u548c\u5b55\u6fc0\u7d20\u7b49\u6fc0\u7d20\u53d7\u4f53\uff0c\u8fd9\u4e9b\u6fc0\u7d20\u4f1a\u4fc3\u8fdb\u5176\u751f\u957f\u3002<\/li>\n<li>\u8bb8\u591a\u60a3\u6709\u8fd9\u79cd\u764c\u75c7\u7684\u60a3\u8005\u9762\u4e34\u75be\u75c5\u8fdb\u5c55\u548c\u6cbb\u7597\u62b5\u6297\u7684\u6311\u6218\u3002<\/li>\n<\/ul>\n<h3>PI3K \u901a\u8def\u7684\u4f5c\u7528<\/h3>\n<p>\u7531\u4e8e PIK3CA \u7a81\u53d8\uff0cPI3K \u901a\u8def\u5728 HR \u9633\u6027\u4e73\u817a\u764c\u4e2d\u901a\u5e38\u8fc7\u4e8e\u6d3b\u8dc3\u3002\u8fd9\u4f7f\u5f97\u764c\u75c7\u5bf9\u6807\u51c6\u6fc0\u7d20\u6cbb\u7597\u4ea7\u751f\u62b5\u6297\u3002<\/p>\n<h2>Inavolisib \u5982\u4f55\u53d1\u6325\u4f5c\u7528\uff1f<\/h2>\n<p>Inavolisib \u662f\u4e00\u79cd\u53e3\u670d\u836f\u7269\uff0c\u9776\u5411 PIK3CA \u7a81\u53d8\uff0c\u8fd9\u79cd\u7a81\u53d8\u5b58\u5728\u4e8e\u7ea6 40% \u7684 HR \u9633\u6027\u4e73\u817a\u764c\u4e2d\u3002\u8fd9\u4e9b\u7a81\u53d8\u53ef\u4ee5\u52a0\u901f\u80bf\u7624\u751f\u957f\u5e76\u5bfc\u81f4\u5bf9\u6807\u51c6\u6cbb\u7597\u7684\u62b5\u6297\u3002\u5b83\u7279\u5f02\u6027\u6291\u5236 PI3K\u03b1\uff0c\u4ece\u800c\u51cf\u7f13\u7531\u8fd9\u4e9b\u7a81\u53d8\u9a71\u52a8\u7684\u764c\u75c7\u751f\u957f\u3002<\/p>\n<h2><b>\u7f57\u6c0f\u5bf9\u4e73\u817a\u764c\u7814\u7a76\u7684\u627f\u8bfa<\/b><\/h2>\n<p>\u5173\u4e8e\u7f57\u6c0f<\/p>\n<ul>\n<li>\u7f57\u6c0f\u5728\u4e73\u817a\u764c\u7814\u7a76\u9886\u57df\u5df2\u6df1\u8015 30 \u4f59\u5e74\uff0c\u81f4\u529b\u4e8e\u4e3a\u4e0d\u540c\u7c7b\u578b\u7684\u4e73\u817a\u764c\u60a3\u8005\u5f00\u53d1\u66f4\u597d\u7684\u6cbb\u7597\u65b9\u6848\u3002<\/li>\n<li>\u516c\u53f8\u4e13\u6ce8\u4e8e\u4e2a\u6027\u5316\u533b\u7597\uff0c\u5e76\u81f4\u529b\u4e8e\u5c06 Inavolisib \u7b49\u521b\u65b0\u7597\u6cd5\u5e26\u7ed9\u6709\u9700\u8981\u7684\u60a3\u8005\u3002<\/li>\n<\/ul>\n<p>\u4e0b\u4e00\u6b65<\/p>\n<ul>\n<li>\u7f57\u6c0f\u8ba1\u5212\u5c06\u8fd9\u9879\u7814\u7a76\u7684\u6570\u636e\u63d0\u4ea4\u7ed9\u536b\u751f\u5f53\u5c40\uff0c\u4ee5\u4fbf\u5c3d\u5feb\u5c06\u8fd9\u79cd\u6cbb\u7597\u65b9\u6848\u63d0\u4f9b\u7ed9\u60a3\u8005\u3002<\/li>\n<li>PIK3CA \u7a81\u53d8\u5bfc\u81f4\u5bf9\u4f20\u7edf\u6fc0\u7d20\u7597\u6cd5\u7684\u62b5\u6297\u3002<\/li>\n<\/ul>\n<p><strong>\u6765\u6e90\uff1a<\/strong><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive\" target=\"_blank\" rel=\"noopener nofollow\">FDA \u6279\u51c6<\/a><\/p>\n<p><a href=\"https:\/\/www.roche.com\/media\/releases\/med-cor-2023-12-08\" target=\"_blank\" rel=\"noopener nofollow\">\u7f57\u6c0f\u65b0\u95fb<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>2024\u5e7410\u670810\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6 Inavolisib \u8054\u5408 Palbocicli [&hellip;]<\/p>\n","protected":false},"author":124,"featured_media":137012,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6122,6122,5954,5954],"tags":[],"class_list":["post-39179","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cancer-medicine","category-generic-drugs"],"_links":{"self":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts\/39179","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/users\/124"}],"replies":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/comments?post=39179"}],"version-history":[{"count":0,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts\/39179\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/media\/137012"}],"wp:attachment":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/media?parent=39179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/categories?post=39179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/tags?post=39179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}