{"id":62477,"date":"2026-06-22T20:14:00","date_gmt":"2026-06-22T13:14:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=62477"},"modified":"2026-06-22T20:14:00","modified_gmt":"2026-06-22T13:14:00","slug":"laboratoires-pierre-fabre-receives-european-commission-approval-for-braftovi-encorafenib-in-combination-with-cetuximab-and-folfox-fluorouracil-leucovorin-and-oxaliplatin-for-the-first-line","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=62477","title":{"rendered":"Laboratoires Pierre Fabre receives European Commission Approval 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\/2725709\/6009534\/Pierre_Fabre_Laboratories_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>European approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab and mFOLFOX6 demonstrated 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 oxaliplatin-based <\/i><i>chemotherapy with or without bevacizumab<\/i><\/li>\n<li><i>This regimen is the first and only combination with a BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF<\/i><sup>V600E<\/sup><i>-mutant mCRC<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CASTRES, France<\/span>, <span class=\"legendSpanClass\">June 22, 2026<\/span> \/PRNewswire\/ &#8212;\u00a0Laboratoires Pierre Fabre announced today that the European Commission (EC) has approved 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\u00a0metastatic colorectal cancer (mCRC). The approval is based on the 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><b>Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: <\/b>&#8220;We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant\u00a0mCRC. Today&#8217;s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited.&#8221;<\/p>\n<p>In the Phase 3 BREAKWATER trial, 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 oxaliplatin-based chemotherapy with or without bevacizumab (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 (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40\u20134.25; P&lt;0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4) compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.<\/p>\n<p>PDF &#8211;\u00a0<a href=\"https:\/\/mma.prnewswire.com\/media\/2998152\/Pierre_Fabre_Laboratories.pdf\" target=\"_blank\" rel=\"nofollow\">https:\/\/mma.prnewswire.com\/media\/2998152\/Pierre_Fabre_Laboratories.pdf<\/a><\/p>\n<p>Contact :<br \/><a href=\"mailto:laure.sgandurra@pierre-fabre.com\" target=\"_blank\" rel=\"nofollow\">laure.sgandurra@pierre-fabre.com<\/a><\/p>","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\/2725709\/6009534\/Pierre_Fabre_Laboratories_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>European approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab and mFOLFOX6 demonstrated 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 oxaliplatin-based <\/i><i>chemotherapy with or without bevacizumab<\/i><\/li>\n<li><i>This regimen is the first and only combination with a BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF<\/i><sup>V600E<\/sup><i>-mutant mCRC<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">CASTRES, France<\/span>, <span class=\"legendSpanClass\">June 22, 2026<\/span> \/PRNewswire\/ &#8212;\u00a0Laboratoires Pierre Fabre announced today that the European Commission (EC) has approved 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\u00a0metastatic colorectal cancer (mCRC). The approval is based on the 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><b>Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: <\/b>&#8220;We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with <i>BRAF<\/i><sup>V600E<\/sup>-mutant\u00a0mCRC. Today&#8217;s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited.&#8221;<\/p>\n<p>In the Phase 3 BREAKWATER trial, 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 oxaliplatin-based chemotherapy with or without bevacizumab (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 (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40\u20134.25; P&lt;0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4) compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.<\/p>\n<p>PDF &#8211;\u00a0<a href=\"https:\/\/mma.prnewswire.com\/media\/2998152\/Pierre_Fabre_Laboratories.pdf\" target=\"_blank\" rel=\"nofollow\">https:\/\/mma.prnewswire.com\/media\/2998152\/Pierre_Fabre_Laboratories.pdf<\/a><\/p>\n<p>Contact :<br \/><a href=\"mailto:laure.sgandurra@pierre-fabre.com\" target=\"_blank\" rel=\"nofollow\">laure.sgandurra@pierre-fabre.com<\/a><\/p>\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-62477","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\/62477","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=62477"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/62477\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=62477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=62477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}