{"id":57681,"date":"2024-07-27T00:03:31","date_gmt":"2024-07-27T00:03:31","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/07\/27\/pierre-fabre-laboratories-receives-chmp-positive-opinion-for-braftovi-encorafenib-in-combination-with-mektovi-binimetinib-for-the-treatment-of-adult-patients-with-advanced-non-small-ce\/"},"modified":"2024-07-27T00:03:31","modified_gmt":"2024-07-27T00:03:31","slug":"pierre-fabre-laboratories-receives-chmp-positive-opinion-for-braftovi-encorafenib-in-combination-with-mektovi-binimetinib-for-the-treatment-of-adult-patients-with-advanced-non-small-ce","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/pierre-fabre-laboratories-receives-chmp-positive-opinion-for-braftovi-encorafenib-in-combination-with-mektovi-binimetinib-for-the-treatment-of-adult-patients-with-advanced-non-small-ce\/","title":{"rendered":"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with MEKTOVI\u00ae (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation"},"content":{"rendered":"<div>\n<ul type=\"disc\">\n<li><i>The positive\u00a0CHMP opinion is based on results from the Phase II PHAROS trial,<sup>[<\/sup><sup>1]<\/sup> which demonstrated an objective response rate (ORR) of<\/i>\u00a0<i>75% in treatment-na\u00efve patients and 46% in previously treated patients.<\/i>\u00a0<i>The safety profile is consistent with that observed in the approved metastatic melanoma indication<sup>[<\/sup><sup>1]<\/sup><\/i><\/li>\n<li><i>The European Commission decision for BRAFTOVI<sup>\u00ae<\/sup> (encorafenib) + MEKTOVI<sup>\u00ae<\/sup> (binimetinib) is expected later this year.<\/i><\/li>\n<\/ul>\n<p>CASTRES, <span class=\"xn-location\">France<\/span>, <span class=\"xn-chron\">July 26, 2024<\/span> \/PRNewswire\/ &#8212; Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of BRAFTOVI<sup>\u00ae <\/sup>(encorafenib) in combination with MEKTOVI<sup>\u00ae<\/sup> (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a <i>BRAF<sup>V600E<\/sup> <\/i>mutation. The positive opinion will now be submitted to the European Commission (EC) with a decision on EU marketing authorisation (MA) expected later this year.<\/p>\n<p><span class=\"xn-person\">Eric Ducournau<\/span>, Chief Executive Officer, Pierre Fabre Laboratories said: &#8220;<i>The positive CHMP opinion marks a pivotal step in our commitment to delivering an additional effective targeted treatment option for patients with advanced NSCLC with a <\/i><i>BRAF<sup>V600E<\/sup><\/i><i>\u00a0mutation, who at present have limited treatment options. We look forward to the European Commission&#8217;s decision to make BRAFTOVI<sup>\u00ae<\/sup> + MEKTOVI<sup>\u00ae<\/sup> available to non-small cell lung cancer patients in <span class=\"xn-location\">Europe<\/span><\/i>.&#8221;<\/p>\n<p>The CHMP positive opinion is supported by data from the global, open-label, multicentre, non-randomised Phase II PHAROS trial, which included 98 patients from 56 study centres across 5 countries.<sup>[<\/sup><sup>1]<\/sup><\/p>\n<p>At primary analysis (cut-off date: <span class=\"xn-chron\">September 22, 2022<\/span>), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. The PHAROS trial showed that in patients with advanced NSCLC with a <i>BRAF<sup>V600E<\/sup> <\/i>mutation, BRAFTOVI<sup>\u00ae<\/sup> and MEKTOVI<sup>\u00ae<\/sup> provided a meaningful clinical benefit with an ORR of 75% (95% CI: 62, 85) in treatment na\u00efve patients (n=59), with 59% of them maintaining their\u00a0response for at least 12 months. For those patients who had received prior therapy (n=39), the ORR was 46% (95% CI: 30, 63), with 33% maintaining their response for at least 12 months.<sup>[<\/sup><sup>1]<\/sup><\/p>\n<p>CONTACT: Laurence MARCHAL <a href=\"mailto:laurence.marchal@pierre-fabre.com\" target=\"_blank\" rel=\"nofollow noopener\">laurence.marchal@pierre-fabre.com<\/a><\/p>\n<div id=\"prni_dvprnejpg2988left\" dir=\"ltr\" style=\"TEXT-ALIGN: center; WIDTH: 100%\">   <a href=\"https:\/\/mma.prnasia.com\/media2\/2416854\/Pierre_Fabre_Laboratories.jpg?p=medium600\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" id=\"prnejpg2988left\" title=\"\" src=\"https:\/\/mma.prnasia.com\/media2\/2416854\/Pierre_Fabre_Laboratories.jpg?p=medium600\" alt=\"\" align=\"middle\"><\/a>   <br \/>   <span><\/span>  <\/div>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The positive\u00a0CHMP opinion is based on results from the Phase II PHAROS trial,[1] which demonstrated an objective response rate (ORR) of\u00a075% in treatment-na\u00efve patients and 46% in previously treated patients.\u00a0The safety profile is consistent with that observed in the approved metastatic melanoma indication[1] The European Commission decision for BRAFTOVI\u00ae (encorafenib) + MEKTOVI\u00ae (binimetinib) is expected [&#8230;]\n","protected":false},"author":1,"featured_media":79226,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-57681","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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