{"id":48985,"date":"2018-09-25T01:00:00","date_gmt":"2018-09-26T01:53:48","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/%e9%80%9f%e9%80%92-fda%e6%89%b9%e5%87%86%e6%8a%97%e7%99%8c%e6%96%b0%e8%8d%af%ef%bc%8c%e6%b2%bb%e7%96%97%e4%b8%89%e7%a7%8d%e6%b7%8b%e5%b7%b4%e7%98%a4\/"},"modified":"2018-09-26T09:53:50","modified_gmt":"2018-09-26T01:53:50","slug":"%e9%80%9f%e9%80%92-fda%e6%89%b9%e5%87%86%e6%8a%97%e7%99%8c%e6%96%b0%e8%8d%af%ef%bc%8c%e6%b2%bb%e7%96%97%e4%b8%89%e7%a7%8d%e6%b7%8b%e5%b7%b4%e7%98%a4","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/48985\/","title":{"rendered":"\u901f\u9012 | FDA\u6279\u51c6\u6297\u764c\u65b0\u836f\uff0c\u6cbb\u7597\u4e09\u79cd\u6dcb\u5df4\u7624"},"content":{"rendered":"
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\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/h1>\n

\u4eca\u65e5\uff0c\u7f8e\u56fdFDA\u5ba3\u5e03\uff0c\u6279\u51c6Verastem Oncology\u516c\u53f8\u7684\u6297\u764c\u65b0\u836fCopiktra\uff08duvelisib\uff09\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u5df2\u7ecf\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e24\u6b21\u524d\u671f\u7597\u6cd5\u7684\u590d\u53d1\/\u96be\u6cbb\u6027\u6162\u6027\u6dcb\u5df4\u6027\u767d\u8840\u75c5\uff08CLL\uff09\u548c\u5c0f\u6dcb\u5df4\u7ec6\u80de\u6dcb\u5df4\u7624\uff08SLL\uff09\u6210\u5e74\u60a3\u8005\u3002<\/strong>\u540c\u65f6FDA\u901a\u8fc7\u52a0\u901f\u6279\u51c6\uff08accelerated approval\uff09\uff0c\u6279\u51c6Copiktra\u6cbb\u7597\u81f3\u5c11\u63a5\u53d7\u8fc7\u4e24\u6b21\u524d\u671f\u7597\u6cd5\u7684\u590d\u53d1\/\u96be\u6cbb\u6027\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\uff08FL\uff09\u6210\u5e74\u60a3\u8005<\/strong>\u3002<\/span>
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\u6dcb\u5df4\u7624\u662f\u6700\u5e38\u89c1\u7684\u8840\u764c\u7c7b\u578b\u3002Copiktra\u6cbb\u7597\u7684\u4e09\u79cd\u8840\u764c\u7c7b\u578b\u5c5e\u4e8e\u60f0\u6027\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08indolent non-Hodgkin lymphoma\uff09\u3002\u636e\u7edf\u8ba1\uff0c\u5728\u7f8e\u56fd\u6709681\uff0c000\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u60a3\u8005\u3002\u5176\u4e2d\uff0c\u5927\u7ea6\u6709350\uff0c000\u540dCLL\uff0cSLL\u548cFL\u60a3\u8005\u3002CLL\uff0cSLL\u548cFL\u867d\u7136\u76ee\u524d\u90fd\u5b58\u5728\u6709\u6548\u7597\u6cd5\uff0c\u4f46\u662f\u771f\u5b9e\u4e16\u754c\u6570\u636e\u8868\u660e\uff0c\u5f88\u591a\u60a3\u8005\u5728\u63a5\u53d7\u6cbb\u7597\u540e\uff0c\u764c\u75c7\u4f1a\u518d\u5ea6\u590d\u53d1\uff0c\u6216\u5bf9\u7597\u6cd5\u4ea7\u751f\u6297\u6027\u3002\u8fd9\u4e9b\u60a3\u8005\u4ee3\u8868\u7740\u663e\u8457\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002<\/span><\/p>\n


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Verastem\u516c\u53f8\u5f00\u53d1\u7684Copiktra\u662f\u4e00\u79cdPI3K\u86cb\u767d\u6fc0\u9176\u7684\u521b\u65b0\u53e3\u670d\u6291\u5236\u5242\u3002\u5b83\u80fd\u591f\u540c\u65f6\u6291\u5236PI3K-\u03b4\u548cPI3K-\u03b3\u7684\u6d3b\u6027\u3002\u8fd9\u4e24\u79cd\u86cb\u767d\u6fc0\u9176\u5e2e\u52a9\u652f\u6301\u764c\u53d8B\u7ec6\u80de\u7684\u751f\u5b58\u548c\u589e\u957f\u3002Copiktra\u7684\u65b0\u836f\u7533\u8bf7\u83b7\u5f97\u4e86FDA\u6388\u4e88\u7684\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002\u6b64\u524d\uff0cCopiktra\u8fd8\u83b7\u5f97\u4e86FDA\u6388\u4e88\u7684\u5feb\u901f\u901a\u9053\u8d44\u683c\u548c\u5b64\u513f\u836f\u8d44\u683c\u3002<\/strong><\/span><\/p>\n


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\u6cbb\u7597CLL\u548cSLL\u7684\u6279\u51c6\u662f\u57fa\u4e8e\u4e00\u9879\u591a\u4e2d\u5fc3\u968f\u673a\u5f00\u653e\u6807\u7b7e\u76843\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8be5\u5b9e\u9a8c\u6bd4\u8f83\u4e86duvelisib\u548c\u76ee\u524d\u6cbb\u7597CLL\u548cSLL\u7684\u6807\u51c6\u7597\u6cd5\u5728\u6cbb\u7597\u590d\u53d1\/\u96be\u6cbb\u6027CLL\u6216SLL\u60a3\u8005\u65f6\u7684\u7597\u6548\u3002\u5728\u5df2\u7ecf\u63a5\u53d7\u8fc7\u81f3\u5c112\u6b21\u6cbb\u7597\u7684196\u540d\u60a3\u8005\u4e2d\uff0cduvelisib\u7ec4\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a16.4\u4e2a\u6708\uff0c\u6d3b\u6027\u5bf9\u7167\u7ec4\u4e3a9.1\u4e2a\u6708\u3002\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u5206\u522b\u4e3a78%\uff08duvelisib\u7ec4\uff09\u548c39%\uff08\u6d3b\u6027\u5bf9\u7167\u7ec4\uff09\u3002<\/strong><\/span><\/p>\n


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\u6cbb\u7597FL\u7684\u6279\u51c6\u662f\u57fa\u4e8e\u4e00\u9879\u5355\u81c2\u591a\u4e2d\u5fc32\u671f\u4e34\u5e8a\u8bd5\u9a8c\u300283\u540d\u5bf9rituximab\u548c\u5316\u7597\u6216\u653e\u7597\u4ea7\u751f\u6297\u6027\u7684FL\u60a3\u8005\u63a5\u53d7\u4e86duvelisib\u7684\u6cbb\u7597\u3002ORR\u4e3a42%\uff0c\u5176\u4e2d41%\u7684\u60a3\u8005\u4e3a\u90e8\u5206\u7f13\u89e3\uff0c1\u540d\u60a3\u8005\u4e3a\u5b8c\u5168\u7f13\u89e3<\/strong>\u3002\u5728\u83b7\u5f97\u7f13\u89e3\u7684\u60a3\u8005\u4e2d\uff0c43%\u7684\u60a3\u8005\u7f13\u89e3\u671f\u8d85\u8fc76\u4e2a\u6708\uff0c17%\u7684\u60a3\u8005\u7f13\u89e3\u671f\u8d85\u8fc712\u4e2a\u6708\u3002<\/strong><\/span><\/p>\n


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\"\u901f\u9012<\/p>\n

<\/span>\u25b2Verastem Oncology\u516c\u53f8\u603b\u88c1\u517cCEO Robert Forrester\u5148\u751f\uff08\u56fe\u7247\u6765\u6e90\uff1aVerastem Oncology\u516c\u53f8\u5b98\u7f51\uff09<\/span><\/strong><\/p>\n


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\u201c\u4eca\u5929FDA\u5bf9Copiktra\u7684\u6279\u51c6\u8868\u660e\uff0cVerastem\u516c\u53f8\u5728\u5b9e\u73b0\u4e3a\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u521b\u65b0\u53e3\u670d\u7597\u6cd5\u7684\u627f\u8bfa\uff0c\u201d<\/span>Verastem\u516c\u53f8\u7684\u603b\u88c1\u517cCEO<\/span> Robert Forrester\u5148\u751f\u8bf4\uff1a\u201c\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u80fd\u591f\u5728\u5168\u56fd\u8840\u6db2\u764c\u75c7\u5ba3\u4f20\u6708\uff08National Blood Cancer Awareness Month\uff09\u63a8\u51faCopiktra\u3002\u6211\u4eec\u81f4\u529b\u4e8e\u63a8\u52a8\u50cfCopiktra\u8fd9\u6837\u80fd\u591f\u7ed9\u60a3\u8005\u548c\u4ed6\u4eec\u7684\u533b\u62a4\u4eba\u5458\u5e26\u6765\u91cd\u5927\u5f71\u54cd\u7684\u7597\u6cd5\u7684\u7814\u7a76\u3002\u6211\u4eec\u975e\u5e38\u611f\u8c22\u53c2\u4e0eduvelisib\u4e34\u5e8a\u8bd5\u9a8c\u7684\u591a\u4f4d\u60a3\u8005\uff0c\u662f\u4ed6\u4eec\u591a\u5e74\u7684\u53c2\u4e0e\u5e26\u6765\u4e86\u8fd9\u4e00\u5173\u952e\u65f6\u523b\u3002\u201d<\/span><\/p>\n


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\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

[1] <\/span>duvelisib<\/span> (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Retrieved September 24, 2018, from https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ucm621503.htm<\/span><\/p>\n

[2] Verastem wins FDA approval for blood cancer drug. Retrieved September 24, 2018, from https:\/\/www.bostonglobe.com\/business\/2018\/09\/24\/verastem-wins-fda-approval-for-blood-cancer-drug\/H7fgXW8ilWyxdg4b12bPOP\/story.html<\/span><\/p>\n

[3] Verastem Oncology Receives FDA Approval of COPIKTRA\u2122 (<\/span>duvelisib<\/span>) Capsules. Retrieved September 24, 2018, from http:\/\/investor.verastem.com\/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2368647<\/span><\/p>\n


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\u672c\u6587\u6765\u81ea\u836f\u660e\u5eb7\u5fb7\u5fae\u4fe1\u56e2\u961f\uff0c\u6b22\u8fce\u8f6c\u53d1\u5230\u670b\u53cb\u5708\uff0c\u8c22\u7edd\u8f6c\u8f7d\u5230\u5176\u4ed6\u5e73\u53f0\uff1b\u5982\u6709\u5f00\u8bbe\u767d\u540d\u5355\u9700\u6c42\uff0c\u8bf7\u5728\u6587\u7ae0\u5e95\u90e8\u7559\u8a00\uff1b\u5982\u6709\u5176\u4ed6\u5408\u4f5c\u9700\u6c42\uff0c\u8bf7\u8054\u7cfbwuxi_media@wuxiapptec.com<\/span>
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\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u258e\u836f\u660e\u5eb7\u5fb7\/\u62a5\u9053 \u4eca\u65e5\uff0c\u7f8e\u56fdFDA\u5ba3\u5e03\uff0c\u6279\u51c6Verastem Oncology\u516c\u53f8\u7684\u6297\u764c\u65b0\u836fCopiktra\uff08 […]<\/p>\n","protected":false},"author":1,"featured_media":48986,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/48985"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=48985"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/48985\/revisions"}],"predecessor-version":[{"id":48990,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/48985\/revisions\/48990"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/48986"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=48985"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=48985"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=48985"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}