{"id":52646,"date":"2018-09-26T01:00:00","date_gmt":"2018-09-30T01:36:11","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e5%bf%ab%e7%9f%b3%e8%8d%af%e6%8b%bf%e4%b8%8b%e5%89%8d%e6%97%a5fda%e6%89%b9%e5%87%86%e7%9a%84%e8%a1%80%e6%b6%b2%e7%98%a4%e8%8d%af%e7%89%a9%e6%8e%88%e6%9d%83\/"},"modified":"2018-09-30T09:36:14","modified_gmt":"2018-09-30T01:36:14","slug":"%e5%bf%ab%e7%9f%b3%e8%8d%af%e6%8b%bf%e4%b8%8b%e5%89%8d%e6%97%a5fda%e6%89%b9%e5%87%86%e7%9a%84%e8%a1%80%e6%b6%b2%e7%98%a4%e8%8d%af%e7%89%a9%e6%8e%88%e6%9d%83","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/52646\/","title":{"rendered":"\u5feb!\u77f3\u836f\u62ff\u4e0b\u524d\u65e5FDA\u6279\u51c6\u7684\u8840\u6db2\u7624\u836f\u7269\u6388\u6743~"},"content":{"rendered":"
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1.\u6ce2\u58eb\u987f\u65f6\u95f49\u670824\u65e5\uff0cVerastem Oncology \u5ba3\u5e03\u516c\u53f8\u7684\u65b0\u836fCOPIKTRA\u2122 (duvelisib) Capsules\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\u3002<\/strong><\/p>\n


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\"\u5feb!\u77f3\u836f\u62ff\u4e0b\u524d\u65e5FDA\u6279\u51c6\u7684\u8840\u6db2\u7624\u836f\u7269\u6388\u6743~\"<\/p>\n

https:\/\/www.verastem.com\/wp-content\/uploads\/2018\/08\/prescribing-information.pdf<\/span><\/p>\n


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2.Indications and Usage\uff08\u9002\u5e94\u75c7\uff09<\/strong><\/p>\n


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\uff081\uff09Chronic Lymphocytic Leukemia (CLL)\/Small Lymphocytic Lymphoma (SLL)<\/strong><\/p>\n

COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies.\uff08\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\uff09<\/p>\n


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\uff082\uff09Follicular Lymphoma (FL)*<\/strong><\/p>\n

COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.\uff08\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\uff09<\/p>\n

*This indication is approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.<\/p>\n


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3.\u516c\u53f8Pipeline:<\/strong><\/p>\n


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\"\u5feb!\u77f3\u836f\u62ff\u4e0b\u524d\u65e5FDA\u6279\u51c6\u7684\u8840\u6db2\u7624\u836f\u7269\u6388\u6743~\"<\/p>\n


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4.9\u670825\u65e5 Verastem Oncology\u5ba3\u5e03\uff1a<\/strong>CSPC Pharmaceutical Group Limited and Verastem Oncology Sign Exclusive License Agreement for the Development and Commercialization of COPIKTRA\u2122 (duvelisib) in China.<\/p>\n


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 Verastem Oncology\u5c06\u6536\u52301500\u4e07\u7f8e\u5143\u9996\u4ed8\u6b3e\uff1b\u989d\u59163000\u4e07\u7f8e\u5143\u7684\u5f00\u53d1\u91cc\u7a0b\u91d1\uff0c\u9500\u552e\u91cc\u7a0b\u7891\u4ed8\u6b3e\uff0c\u548c\u4e24\u4f4d\u6570\u7684\u9500\u552e\u51c0\u63d0\u6210\u3002<\/p>\n

http:\/\/investor.verastem.com\/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2368922<\/span>
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\u8fd9\u4e2a\u4ea4\u6613\u4e0d\u77e5\u9053\u8c08\u4e86\u591a\u4e45\uff0c\u4e0b\u624b\u633a\u5feb\uff0c\u65e9\u524d\u5728\u4e8c\u7ea7<\/span>\u5e02\u573a\u53ef\u80fd\u66f4\u4fbf\u5b9c\uff01 the Oral Inhibitor of Phosphoinositide 3-Kinase (PI3K), and the First Approved Dual Inhibitor of PI3K-delta and PI3K-gamma (PI3K-\u03b4,\u03b3), COPIKTRA (duvelisib)\u3002<\/span><\/p>\n


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

NMPA\/FDA\uff1b<\/span><\/p>\n

\u836f\u878d\u6570\u636e\uff0cPharnex  Datamonitor\uff1b<\/span><\/p>\n

\u76f8\u5173\u516c\u53f8\u516c\u5f00\u62ab\u9732\u7b49\u3002<\/span><\/p>\n


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\"\u5feb!\u77f3\u836f\u62ff\u4e0b\u524d\u65e5FDA\u6279\u51c6\u7684\u8840\u6db2\u7624\u836f\u7269\u6388\u6743~\"<\/p>\n


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\u836f\u878d\u5708\u4e3a\u836f\u7269\u7b80\u8baf\u5408\u4f5c\u5e73\u53f0.<\/span>
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1.\u6ce2\u58eb\u987f\u65f6\u95f49\u670824\u65e5\uff0cVerastem Oncology \u5ba3\u5e03\u516c\u53f8\u7684\u65b0\u836fCOPIKTRA\u2122 (duveli […]<\/p>\n","protected":false},"author":1,"featured_media":52647,"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\/52646"}],"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=52646"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52646\/revisions"}],"predecessor-version":[{"id":52651,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52646\/revisions\/52651"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/52647"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=52646"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=52646"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=52646"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}