# Laboratoires Pierre Fabre receives European Commission Approval for BRAFTOVI® (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)

- Link: https://www.thailand-business-news.com/pr-news/laboratoires-pierre-fabre-receives-european-commission-approval-for-braftovi-encorafenib-in-combination-with-cetuximab-and-folfox-fluorouracil-leucovorin-and-oxaliplatin-for-the-first-line
- Published: 2026-06-22T20:14:00+07:00
- Author: PR Newswire

|   |

 ◦ _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  progression-free survival (PFS), and a significant overall
   survival (OS) benefit, reducing the risk of death by 51% vs oxaliplatin-based
   __chemotherapy with or without bevacizumab_
 ◦ _This regimen is the first and only combination with a BRAF-targeted therapy 
   approved for the first-line treatment of adult patients with BRAF_^(V600E)_-mutant
   mCRC_

CASTRES, France, June 22, 2026 /PRNewswire/ — Laboratoires Pierre Fabre announced
today that the European Commission (EC) has approved BRAFTOVI^(® )(encorafenib) 
in combination with cetuximab and FOLFOX for the first-line treatment of adult patients
with _BRAF_^(V600E)-mutant metastatic colorectal cancer (mCRC). The approval is 
based on the results from the Phase 3 BREAKWATER trial, which assessed the efficacy
and safety of BRAFTOVI^(®) in combination with cetuximab and mFOLFOX6 in patients
with previously untreated _BRAF_^(V600E)-mutant mCRC, compared with oxaliplatin-
based chemotherapy, with or without bevacizumab.

**Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: **"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 _BRAF_
^(V600E)-mutant mCRC. Today’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."

In the Phase 3 BREAKWATER trial, the regimen of BRAFTOVI^(®) 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<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: 1.40–4.25; P<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.

PDF – [https://mma.prnewswire.com/media/2998152/Pierre_Fabre_Laboratories.pdf](https://mma.prnewswire.com/media/2998152/Pierre_Fabre_Laboratories.pdf)

Contact :
[laure.sgandurra@pierre-fabre.com](https://www.thailand-business-news.com/pr-news/laure.sgandurra@pierre-fabre.com)

---

  |  This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. |

---

 
**Read the original article :** [Laboratoires Pierre Fabre receives European Commission Approval for BRAFTOVI® (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) ](http://www.prnasia.com/story/archive/4987118_AE87118_0?rand=184833)