{"id":16352,"date":"2023-02-24T13:29:00","date_gmt":"2023-02-24T13:29:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4024173_AE24173_0"},"modified":"2023-02-24T13:29:00","modified_gmt":"2023-02-24T13:29:00","slug":"servier-receives-a-positive-chmp-opinion-for-tibsovo-in-idh1-mutated-acute-myeloid-leukemia-aml-and-cholangiocarcinoma-cca-patients","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=16352","title":{"rendered":"Servier receives a positive CHMP opinion for Tibsovo\u00ae in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1914957\/Servier_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><b>Tibsovo<sup>\u00ae<\/sup> (ivosidenib tablets) is the first IDH1 inhibitor recommended for approval in <span class=\"xn-location\">Europe<\/span><\/b><\/li>\n<li><b>The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studies<\/b><\/li>\n<\/ul>\n<p><span class=\"xn-location\">PARIS<\/span>, <span class=\"xn-chron\">Feb. 24, 2023<\/span> \/PRNewswire\/ &#8212; Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo<sup>\u00ae<\/sup> (ivosidenib tablets) &#8211; an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme &#8211; for two indications:<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2009416\/PR___Servier.pdf?p=original\" target=\"_blank\" rel=\"nofollow noopener\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2009416\/PR___Servier.pdf?p=pdfthumbnail\" title alt> <\/a> <br \/><span><\/span><\/p>\n<\/p><\/div>\n<ul type=\"disc\">\n<li>in combination with azacitidine, for the treatment of adult patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia and not eligible for standard induction chemotherapy,<\/li>\n<li>in monotherapy, for the treatment of adult patients with locally advanced or metastatic IDH1-mutated Cholangiocarcinoma, previously treated by at least one prior line of systemic therapy.<\/li>\n<\/ul>\n<p><b><span class=\"xn-person\">Claude Bertrand<\/span>, Executive Vice President R&amp;D of Servier, said: <\/b><i>&#8220;The positive CHMP opinion is a further step towards the availability, in the European Union, of Tibsovo<sup>\u00ae<\/sup> which is the first IDH1 inhibitor to be recommended for approval in <span class=\"xn-location\">Europe<\/span> for patients with Acute Myeloid Leukemia and Cholangiocarcinoma for whom therapeutic options are very limited. Tibsovo<sup>\u00ae<\/sup> is an illustration of the Group&#8217;s transformation and commitment in oncology which focuses its research on hard-to-treat cancers with the development of targeted therapies being a promising path for patients.&#8221;<\/i>&nbsp;<\/p>\n<p>The positive CHMP opinion is based on clinical data from the AGILE (AML) and ClarIDHy (CCA) studies.<\/p>\n<p>The CHMP&#8217;s positive opinion on Tibsovo<sup>\u00ae<\/sup> in IDH1 mutated AML and CCA patients will be referred to the European Commission (EC) which will deliver a final decision in the coming months. The decision will be applicable to all 27 EU member states plus <span class=\"xn-location\">Iceland<\/span>, <span class=\"xn-location\">Norway<\/span>, <span class=\"xn-location\">Northern Ireland<\/span> and <span class=\"xn-location\">Liechtenstein<\/span>.<\/p>\n<p><span>PDF &#8211;&nbsp;<\/span><a href=\"https:\/\/mma.prnewswire.com\/media\/2009347\/PR___Servier.pdf\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/mma.prnewswire.com\/media\/2009347\/PR___Servier.pdf<\/a><\/p>\n<p>Contact: <a href=\"mailto:presse@servier.com\" rel=\"nofollow\">presse@servier.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tibsovo\u00ae (ivosidenib tablets) is the first IDH1 inhibitor recommended for approval in Europe The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studies PARIS, Feb. 24, 2023 \/PRNewswire\/ &#8212; Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":16353,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-16352","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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