{"id":57772,"date":"2026-05-25T20:40:00","date_gmt":"2026-05-25T13:40:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=57772"},"modified":"2026-05-25T20:40:00","modified_gmt":"2026-05-25T13:40:00","slug":"pierre-fabre-laboratories-receives-chmp-positive-opinion-for-braftovi-encorafenib-in-combination-with-cetuximab-and-folfox-fluorouracil-leucovorin-and-oxaliplatin-for-the-first-line-treatm","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=57772","title":{"rendered":"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2986842\/Pierre_Fabre_Oncology_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><i>This positive CHMP opinion is based on results from the <\/i><i>Phase 3 BREAKWATER trial, which showed that encorafenib in combination with cetuximab and <\/i><i>mFOLFOX6<\/i><i>\u00a0demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate (ORR) and\u00a0 progression-free survival (PFS), and a significant overall survival (OS) benefit, reducing the risk of death by 51% vs <\/i><i>chemotherapy <\/i><i>with or without bevacizumab <\/i><\/li>\n<li><i>The European Commission decision is expected later this year. <\/i><i>If approved, the regimen will be the first and only combination with BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF<sup>V600E<\/sup>-mutant metastatic colorectal cancer <\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CASTRES, France<\/span>, <span class=\"legendSpanClass\">May 25, 2026<\/span> \/PRNewswire\/ &#8212;\u00a0Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of BRAFTOVI<sup>\u00ae <\/sup>(encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant metastatic colorectal cancer (mCRC). The positive opinion will be submitted to the European Commission (EC) with a decision on EU marketing authorisation expected later this year.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2987142\/Pierre_Fabre_Lab_CHMP_Opinion.pdf?p=original\" target=\"_blank\" rel=\"nofollow\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2987142\/Pierre_Fabre_Lab_CHMP_Opinion.pdf?p=pdfthumbnail\" title=\"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)\" alt=\"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)\" \/> <\/a> <br \/><span>Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)<\/span><\/p>\n<\/div>\n<p>Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories, said: &#8220;Today&#8217;s positive CHMP opinion marks an important step towards a targeted approach for patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant metastatic colorectal cancer. If approved, it would be the only approved targeted therapy in the EU for this patient population in the first-line setting. This milestone reflects Pierre Fabre Laboratories&#8217; commitment to advancing meaningful innovation in oncology and to working in close partnership with the scientific and medical community to address areas of high unmet need.&#8221;<\/p>\n<p>The CHMP positive opinion is based on results from the Phase 3 BREAKWATER trial which assessed the efficacy and safety of BRAFTOVI<sup>\u00ae<\/sup> in combination with cetuximab and mFOLFOX6 in patients with previously untreated <i>BRAF<\/i><sup>V600E<\/sup>-mutant\u00a0mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.<\/p>\n<p>The regimen of BRAFTOVI<sup>\u00ae<\/sup> in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy with or without bevacizumab\u00a0(median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P&lt;0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set.<\/p>\n<p>Contact: <a href=\"mailto:laure.sgandurra@pierre-fabre.com\" target=\"_blank\" rel=\"nofollow\">laure.sgandurra@pierre-fabre.com<\/a><\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2986842\/Pierre_Fabre_Oncology_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><i>This positive CHMP opinion is based on results from the <\/i><i>Phase 3 BREAKWATER trial, which showed that encorafenib in combination with cetuximab and <\/i><i>mFOLFOX6<\/i><i>\u00a0demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate (ORR) and\u00a0 progression-free survival (PFS), and a significant overall survival (OS) benefit, reducing the risk of death by 51% vs <\/i><i>chemotherapy <\/i><i>with or without bevacizumab <\/i><\/li>\n<li><i>The European Commission decision is expected later this year. <\/i><i>If approved, the regimen will be the first and only combination with BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF<sup>V600E<\/sup>-mutant metastatic colorectal cancer <\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CASTRES, France<\/span>, <span class=\"legendSpanClass\">May 25, 2026<\/span> \/PRNewswire\/ &#8212;\u00a0Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of BRAFTOVI<sup>\u00ae <\/sup>(encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant metastatic colorectal cancer (mCRC). The positive opinion will be submitted to the European Commission (EC) with a decision on EU marketing authorisation expected later this year.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<p> <a href=\"https:\/\/mma.prnasia.com\/media2\/2987142\/Pierre_Fabre_Lab_CHMP_Opinion.pdf?p=original\" target=\"_blank\" rel=\"nofollow\"> <img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2987142\/Pierre_Fabre_Lab_CHMP_Opinion.pdf?p=pdfthumbnail\" title=\"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)\" alt=\"Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)\" \/> <\/a> <br \/><span>Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI\u00ae (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)<\/span><\/p>\n<\/div>\n<p>Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories, said: &#8220;Today&#8217;s positive CHMP opinion marks an important step towards a targeted approach for patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant metastatic colorectal cancer. If approved, it would be the only approved targeted therapy in the EU for this patient population in the first-line setting. This milestone reflects Pierre Fabre Laboratories&#8217; commitment to advancing meaningful innovation in oncology and to working in close partnership with the scientific and medical community to address areas of high unmet need.&#8221;<\/p>\n<p>The CHMP positive opinion is based on results from the Phase 3 BREAKWATER trial which assessed the efficacy and safety of BRAFTOVI<sup>\u00ae<\/sup> in combination with cetuximab and mFOLFOX6 in patients with previously untreated <i>BRAF<\/i><sup>V600E<\/sup>-mutant\u00a0mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.<\/p>\n<p>The regimen of BRAFTOVI<sup>\u00ae<\/sup> in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy with or without bevacizumab\u00a0(median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P&lt;0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set.<\/p>\n<p>Contact: <a href=\"mailto:laure.sgandurra@pierre-fabre.com\" target=\"_blank\" rel=\"nofollow\">laure.sgandurra@pierre-fabre.com<\/a><\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-57772","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/57772","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=57772"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/57772\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=57772"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=57772"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=57772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}