{"id":39177,"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":"2026-07-10T08:45:09","modified_gmt":"2026-07-10T08:45:09","slug":"fda-approval-inavolisib-palbociclib-fulvestrant","status":"publish","type":"post","link":"https:\/\/indogenmed.org\/ja\/resource\/fda-approval-inavolisib-palbociclib-fulvestrant\/","title":{"rendered":"FDA\u3001\u9032\u884c\u6027\u4e73\u304c\u3093\u306b\u5bfe\u3057\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u3001\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\u3001\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u4f75\u7528\u7642\u6cd5\u3092\u627f\u8a8d"},"content":{"rendered":"<p>2024\u5e7410\u670810\u65e5\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u7279\u5b9a\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u9032\u884c\u6027\u4e73\u304c\u3093\u306e\u6210\u4eba\u60a3\u8005\u306b\u5bfe\u3057\u3001<a href=\"\/molecule\/ivosidenib\/\" target=\"_blank\" rel=\"noopener\">\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6<\/a>\u3092<a href=\"\/molecule\/palbociclib\/\" target=\"_blank\" rel=\"noopener\">\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6<\/a>\u304a\u3088\u3073\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u3068\u306e\u4f75\u7528\u3067\u627f\u8a8d\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u627f\u8a8d\u306f\u3001\u4ee5\u4e0b\u306e\u60a3\u8005\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u5185\u5206\u6ccc\u7642\u6cd5\u62b5\u6297\u6027\u4e73\u304c\u3093<\/li>\n<li>PIK3CA\u5909\u7570\u816b\u760d<\/li>\n<li>\u30db\u30eb\u30e2\u30f3\u53d7\u5bb9\u4f53\uff08HR\uff09\u967d\u6027<\/li>\n<li>HER2\u9670\u6027<\/li>\n<li>FDA\u627f\u8a8d\u306e\u691c\u67fb\u3067\u7279\u5b9a\u3055\u308c\u305f\u5c40\u6240\u9032\u884c\u6027\u307e\u305f\u306f\u8ee2\u79fb\u6027\u75be\u60a3<\/li>\n<li>\u4ee5\u524d\u306e\u5185\u5206\u6ccc\u7642\u6cd5\u7d42\u4e86\u5f8c\u306b\u518d\u767a\u3092\u7d4c\u9a13\u3057\u305f<\/li>\n<\/ul>\n<h2><b>\u7814\u7a76\u6982\u8981<\/b><\/h2>\n<p>INAVO120\u8a66\u9a13\u306f\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u3068\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\u304a\u3088\u3073\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u306e\u4f75\u7528\u7642\u6cd5\u3068\u3001\u30d7\u30e9\u30bb\u30dc\u3068\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\u304a\u3088\u3073\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u306e\u4f75\u7528\u7642\u6cd5\u3092\u6bd4\u8f03\u3057\u3001\u305d\u306e\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u3092\u8a55\u4fa1\u3057\u305f\u7b2cIII\u76f8\u81e8\u5e8a\u8a66\u9a13\u3067\u3059\u3002\u3053\u306e\u8a66\u9a13\u306f\u3001\u5c40\u6240\u9032\u884c\u307e\u305f\u306f\u8ee2\u79fb\u3057\u3001\u5185\u5206\u6ccc\u7642\u6cd5\u306b\u62b5\u6297\u6027\u3092\u793a\u3059PIK3CA\u5909\u7570\u3001\u30db\u30eb\u30e2\u30f3\u53d7\u5bb9\u4f53\uff08HR\uff09\u967d\u6027\u3001HER2\u9670\u6027\u306e<a href=\"\/ja\/resource\/symptoms-of-breast-cancer\/\">\u4e73\u304c\u3093<\/a>\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306f\u3001\u3053\u306e\u7814\u7a76\u306e\u4e3b\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u7814\u7a76\u306b\u306f\u3001\u5185\u5206\u6ccc\u7642\u6cd5\u5b8c\u4e86\u5f8c\u306b\u75c5\u72b6\u304c\u60aa\u5316\u3057\u305f\u9032\u884c\u6027\u4e73\u304c\u3093\u60a3\u8005325\u4eba\u304c\u53c2\u52a0\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u60a3\u8005\u306f2\u3064\u306e\u30b0\u30eb\u30fc\u30d7\u306b\u5206\u3051\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n<ul>\n<li>\u4e00\u65b9\u306e\u30b0\u30eb\u30fc\u30d7\u306f\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\uff081\u65e51\u56de9mg\uff09\u3001\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\uff081\u65e51\u56de125mg\u309221\u65e5\u9593\u6295\u4e0e\u5f8c\u30017\u65e5\u9593\u4f11\u85ac\uff09\u3001\u304a\u3088\u3073\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\uff08\u7279\u5b9a\u65e5\u306b500mg\u6295\u4e0e\uff09\u3092\u53d7\u3051\u307e\u3057\u305f\u3002<\/li>\n<li>\u3082\u3046\u4e00\u65b9\u306e\u30b0\u30eb\u30fc\u30d7\u306f\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u306e\u4ee3\u308f\u308a\u306b\u30d7\u30e9\u30bb\u30dc\u3092\u53d7\u3051\u307e\u3057\u305f\u3002<\/li>\n<\/ul>\n<p>\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u306f\u3001\u75c5\u52e2\u9032\u884c\u307e\u305f\u306f\u6b7b\u4ea1\u307e\u3067\u306e\u671f\u9593\u3068\u5b9a\u7fa9\u3055\u308c\u308b\u7121\u5897\u60aa\u751f\u5b58\u671f\u9593\uff08PFS\uff09\u3067\u3057\u305f\u3002<\/p>\n<h2><b>\u7814\u7a76\u7d50\u679c<\/b><\/h2>\n<ul>\n<li>\u4e2d\u592e\u5024PFS\u306f\u3001\u6cbb\u7642\u7fa4\uff08\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\uff0b\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\uff0b\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\uff09\u306715.0\u30f6\u6708\u3067\u3042\u3063\u305f\u306e\u306b\u5bfe\u3057\u3001\u30d7\u30e9\u30bb\u30dc\u7fa4\u3067\u306f7.3\u30f6\u6708\u3067\u3057\u305f\u3002<\/li>\n<li>\u5168\u594f\u52b9\u7387\uff08ORR\uff09\u306f\u3001\u6cbb\u7642\u7fa4\u306758%\u3067\u3042\u3063\u305f\u306e\u306b\u5bfe\u3057\u3001\u30d7\u30e9\u30bb\u30dc\u7fa4\u3067\u306f\u308f\u305a\u304b25%\u3067\u3057\u305f\u3002<\/li>\n<li>\u594f\u52b9\u671f\u9593\uff08DOR\uff09\u306f\u3001\u6cbb\u7642\u7fa4\u306718.4\u30f6\u6708\u3067\u3042\u3063\u305f\u306e\u306b\u5bfe\u3057\u3001\u30d7\u30e9\u30bb\u30dc\u7fa4\u3067\u306f9.6\u30f6\u6708\u3067\u3057\u305f\u3002<\/li>\n<\/ul>\n<h2><b>\u4e00\u822c\u7684\u306a\u526f\u4f5c\u7528<\/b><\/h2>\n<p>\u3053\u306e\u4f75\u7528\u7642\u6cd5\u3092\u53d7\u3051\u305f\u60a3\u8005\u306b\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u526f\u4f5c\u7528\u304c\u898b\u3089\u308c\u307e\u3057\u305f\u3002\u6700\u3082\u4e00\u822c\u7684\u306a\u526f\u4f5c\u7528\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u597d\u4e2d\u7403\u6e1b\u5c11\uff08\u767d\u8840\u7403\u306e\u4e00\u7a2e\uff09<\/li>\n<li>\u30d8\u30e2\u30b0\u30ed\u30d3\u30f3\u6e1b\u5c11\uff08\u8ca7\u8840\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u3042\u308a\uff09<\/li>\n<li>\u7a7a\u8179\u6642\u8840\u7cd6\u5024\u4e0a\u6607<\/li>\n<li>\u53e3\u5185\u708e\uff08\u53e3\u306e\u708e\u75c7\uff09<\/li>\n<li>\u4e0b\u75e2<\/li>\n<li>\u75b2\u52b4<\/li>\n<\/ul>\n<h2><b>\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\u8a3a\u65ad\u85ac\u306e\u627f\u8a8d<\/b><\/h2>\n<p>FoundationOne Liquid CDx\u30a2\u30c3\u30bb\u30a4\u304c\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\u8a3a\u65ad\u30c4\u30fc\u30eb\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u691c\u67fb\u306f\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u3001\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\u3001\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u306e\u6069\u6075\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u4e73\u304c\u3093\u60a3\u8005\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/p>\n<h2><b>\u8fc5\u901f\u627f\u8a8d<\/b><\/h2>\n<p>\u3053\u306e\u627f\u8a8d\u306f\u3001\u8907\u6570\u306e\u56fd\u304c\u304c\u3093\u6cbb\u7642\u85ac\u3092\u540c\u6642\u306b\u5be9\u67fb\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30fb\u30aa\u30fc\u30d3\u30b9\u306e\u4e00\u74b0\u3067\u3057\u305f\u3002FDA\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3001\u30ab\u30ca\u30c0\u3001\u30b9\u30a4\u30b9\u306e\u4fdd\u5065\u5f53\u5c40\u3068\u5354\u529b\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u7533\u8acb\u306f\u512a\u5148\u5be9\u67fb\u304a\u3088\u3073\u753b\u671f\u7684\u6cbb\u7642\u85ac\u6307\u5b9a\u3092\u53d7\u3051\u3001\u4e88\u60f3\u3088\u308a\u30827\u9031\u9593\u65e9\u304f\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<h2><b>\u30db\u30eb\u30e2\u30f3\u53d7\u5bb9\u4f53\u967d\u6027\u4e73\u304c\u3093\u306b\u3064\u3044\u3066<\/b><\/h2>\n<h3>HR\u967d\u6027\u4e73\u304c\u3093\u3068\u306f\uff1f<\/h3>\n<ul>\n<li>\u3053\u306e\u30bf\u30a4\u30d7\u306e\u4e73\u304c\u3093\u306f\u3001\u5168\u4e73\u304c\u3093\u75c7\u4f8b\u306e\u7d0470%\u3092\u5360\u3081\u307e\u3059\u3002<\/li>\n<li>\u816b\u760d\u7d30\u80de\u306b\u306f\u3001\u30a8\u30b9\u30c8\u30ed\u30b2\u30f3\u3084\u30d7\u30ed\u30b2\u30b9\u30c6\u30ed\u30f3\u306a\u3069\u306e\u30db\u30eb\u30e2\u30f3\u306b\u5bfe\u3059\u308b\u53d7\u5bb9\u4f53\u304c\u3042\u308a\u3001\u3053\u308c\u3089\u304c\u816b\u760d\u306e\u5897\u6b96\u3092\u4fc3\u9032\u3057\u307e\u3059\u3002<\/li>\n<li>\u3053\u306e\u30bf\u30a4\u30d7\u306e\u304c\u3093\u60a3\u8005\u306e\u591a\u304f\u306f\u3001\u75c5\u52e2\u9032\u884c\u3084\u6cbb\u7642\u62b5\u6297\u6027\u3068\u3044\u3046\u8ab2\u984c\u306b\u76f4\u9762\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<h3>PI3K\u7d4c\u8def\u306e\u5f79\u5272<\/h3>\n<p>PIK3CA\u5909\u7570\u306e\u305f\u3081\u3001HR\u967d\u6027\u4e73\u304c\u3093\u3067\u306fPI3K\u7d4c\u8def\u304c\u904e\u5270\u306b\u6d3b\u6027\u5316\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u304c\u3093\u306f\u6a19\u6e96\u7684\u306a\u30db\u30eb\u30e2\u30f3\u7642\u6cd5\u306b\u62b5\u6297\u6027\u3092\u793a\u3057\u307e\u3059\u3002<\/p>\n<h2>\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u306e\u4f5c\u7528\u6a5f\u5e8f<\/h2>\n<p>\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u306f\u3001HR\u967d\u6027\u4e73\u304c\u3093\u306e\u7d0440%\u306b\u898b\u3089\u308c\u308bPIK3CA\u5909\u7570\u3092\u6a19\u7684\u3068\u3059\u308b\u7d4c\u53e3\u85ac\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u5909\u7570\u306f\u816b\u760d\u306e\u5897\u6b96\u3092\u52a0\u901f\u3055\u305b\u3001\u6a19\u6e96\u6cbb\u7642\u306b\u5bfe\u3059\u308b\u62b5\u6297\u6027\u3092\u4ed8\u4e0e\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u306fPI3K\u03b1\u3092\u7279\u7570\u7684\u306b\u963b\u5bb3\u3057\u3001\u3053\u308c\u3089\u306e\u5909\u7570\u306b\u3088\u3063\u3066\u99c6\u52d5\u3055\u308c\u308b\u304c\u3093\u306e\u5897\u6b96\u3092\u9045\u3089\u305b\u307e\u3059\u3002\u00a0<\/p>\n<h2><b>\u30ed\u30b7\u30e5\u306e\u4e73\u304c\u3093\u7814\u7a76\u3078\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8<\/b><\/h2>\n<h3>\u30ed\u30b7\u30e5\u306b\u3064\u3044\u3066<\/h3>\n<ul>\n<li>\u30ed\u30b7\u30e5\u306f30\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308a\u4e73\u304c\u3093\u7814\u7a76\u306e\u6700\u524d\u7dda\u306b\u7acb\u3061\u3001\u69d8\u3005\u306a\u7a2e\u985e\u306e\u4e73\u304c\u3093\u60a3\u8005\u306e\u305f\u3081\u306b\u3088\u308a\u826f\u3044\u6cbb\u7642\u6cd5\u3092\u958b\u767a\u3057\u3066\u304d\u307e\u3057\u305f\u3002<\/li>\n<li>\u540c\u793e\u306f\u500b\u5225\u5316\u533b\u7642\u306b\u6ce8\u529b\u3057\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u306e\u3088\u3046\u306a\u9769\u65b0\u7684\u306a\u6cbb\u7642\u6cd5\u3092\u5fc5\u8981\u3068\u3059\u308b\u4eba\u3005\u306b\u5c4a\u3051\u308b\u3088\u3046\u52aa\u3081\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<h3>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h3>\n<ul>\n<li>\u30ed\u30b7\u30e5\u306f\u3001\u3053\u306e\u6cbb\u7642\u6cd5\u3092\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u60a3\u8005\u306b\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u3001\u672c\u7814\u7a76\u306e\u30c7\u30fc\u30bf\u3092\u4fdd\u5065\u5f53\u5c40\u306b\u63d0\u51fa\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002<\/li>\n<li>PIK3CA\u5909\u7570\u306f\u3001\u5f93\u6765\u306e\u30db\u30eb\u30e2\u30f3\u7642\u6cd5\u306b\u5bfe\u3059\u308b\u62b5\u6297\u6027\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<p><strong>\u60c5\u5831\u6e90:<\/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\u627f\u8a8d<\/a><\/p>\n<p><a href=\"https:\/\/www.roche.com\/media\/releases\/med-cor-2023-12-08\" target=\"_blank\" rel=\"noopener nofollow\">\u30ed\u30b7\u30e5\u30cb\u30e5\u30fc\u30b9<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>2024\u5e7410\u670810\u65e5\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u7279\u5b9a\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u9032\u884c\u6027\u4e73\u304c\u3093\u306e\u6210\u4eba\u60a3\u8005\u306b\u5bfe\u3057\u3001\u30a4\u30ca\u30dc\u30ea\u30b7\u30d6\u3092\u30d1\u30eb\u30dc\u30b7\u30af\u30ea\u30d6\u304a\u3088\u3073\u30d5\u30eb\u30d9\u30b9\u30c8\u30e9\u30f3\u30c8\u3068\u306e\u4f75\u7528\u3067\u627f\u8a8d\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u627f\u8a8d\u306f\u3001\u4ee5\u4e0b\u306e\u60a3\u8005\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002  [&hellip;]<\/p>\n","protected":false},"author":124,"featured_media":137012,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6123,5955],"tags":[],"class_list":["post-39177","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cancer-medicine","category-generic-drugs"],"_links":{"self":[{"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/posts\/39177","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/users\/124"}],"replies":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/comments?post=39177"}],"version-history":[{"count":0,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/posts\/39177\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/media\/137012"}],"wp:attachment":[{"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/media?parent=39177"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/categories?post=39177"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/indogenmed.org\/ja\/wp-json\/wp\/v2\/tags?post=39177"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}