{"id":29230,"date":"2024-08-30T12:44:00","date_gmt":"2024-08-30T12:44:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4495076_AE95076_0"},"modified":"2024-08-30T12:44:00","modified_gmt":"2024-08-30T12:44:00","slug":"pierre-fabre-laboratories-receives-european-commission-approval-for-braftoviencorafenib-in-combination-with-mektovi-binimetinib-for-the-treatment-of-adult-patients-with-advanced-non-sm","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=29230","title":{"rendered":"Pierre Fabre Laboratories receives European Commission Approval 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":"<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\/2416854\/4884832\/Pierre_Fabre_Laboratories.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><i>European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to&nbsp;<\/i><\/b><b><i>BRAF<\/i><\/b><b><i>V600E<\/i><\/b><b><i>&nbsp;mutated advanced NSCLC patients with an objective response rate (ORR) of 75% in treatment-na\u00efve patients and 46% in previously treated patients.<sup>[<\/sup><sup>1-3]<\/sup>&nbsp;The safety profile is consistent with that observed in the approved metastatic melanoma indication.<sup>[<\/sup><sup>1]<\/sup><\/i><\/b><\/li>\n<li><b><i>The approval follows a positive opinion issued on <span class=\"xn-chron\">July 25<\/span> by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)<\/i><\/b><\/li>\n<\/ul>\n<p>CASTRES, <span class=\"xn-location\">France<\/span>, <span class=\"xn-chron\">Aug. 30, 2024<\/span> \/PRNewswire\/ &#8212; Pierre Fabre Laboratories announced today that the European Commission (EC) has approved BRAFTOVI<sup>\u00ae&nbsp;<\/sup>(encorafenib) in combination with MEKTOVI<sup>\u00ae<\/sup>&nbsp;(binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a&nbsp;<i>BRAF<sup>V600E<\/sup>&nbsp;<\/i>mutation. The approval is based on the results from the Phase II PHAROS trial, a global, open-label, multicentre, non-randomised trial to determine the efficacy and safety of BRAFTOVI<sup>\u00ae<\/sup>&nbsp;+ MEKTOVI<sup>\u00ae<\/sup>&nbsp;in&nbsp;treatment-na\u00efve and previously treated patients with&nbsp;<i>BRAF<sup>V600E<\/sup><\/i>&nbsp;mutant metastatic NSCLC.<sup>[<\/sup><sup>1]<\/sup><\/p>\n<p>&#8220;We are pleased to be able to extend the treatment of BRAFTOVI<sup>\u00ae&nbsp;<\/sup>(encorafenib) in combination with MEKTOVI<sup>\u00ae<\/sup>&nbsp;(binimetinib) to adult patients with advanced NSCLC with a&nbsp;<i>BRAF<sup>V600E<\/sup>&nbsp;<\/i>mutation in <span class=\"xn-location\">Europe<\/span>&#8221; said <span class=\"xn-person\">Eric Ducournau<\/span>, Chief Executive Officer of Pierre Fabre Laboratories. &#8220;There are currently limited targeted treatment options for&nbsp;<i>BRAF<sup>V600E<\/sup><\/i>&nbsp;mutant NSCLC patients, so this approval is a significant milestone as BRAFTOVI<sup>\u00ae<\/sup>&nbsp;+ MEKTOVI<sup>\u00ae<\/sup>&nbsp;will give patients the option of an additional effective targeted therapy.&#8221;<\/p>\n<p>The EC decision, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 July, is based on the results from the Phase II PHAROS trial.<sup>[<\/sup><sup>1-3]<\/sup>&nbsp;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.&nbsp;In the treatment-na\u00efve population (n=59), the ORR was 75% (95% CI: 62, 85), including 15% complete responses (CRs) and 59% partial responses (PRs).<sup>[<\/sup><sup>1-3]<\/sup>&nbsp;Updated results with an additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months (95% CI: 23.1, not estimable [NE]).<sup>[<\/sup><sup>2,3]<\/sup>*<\/p>\n<p>CONTACT: Laurence MARCHAL, <a href=\"mailto:laurence.marchal@pierre-fabre.com\" rel=\"nofollow\">laurence.marchal@pierre-fabre.com<\/a><\/p>\n<p>PDF &#8211; <a href=\"https:\/\/mma.prnewswire.com\/media\/2493339\/Pierre_Fabre_Approval.pdf\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/mma.prnewswire.com\/media\/2493339\/Pierre_Fabre_Approval.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to&nbsp;BRAFV600E&nbsp;mutated advanced NSCLC patients with an objective response rate (ORR) of 75% in treatment-na\u00efve patients and 46% in previously treated patients.[1-3]&nbsp;The safety profile is consistent with that observed in the approved metastatic melanoma indication.[1] The approval follows [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-29230","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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