The European Commission (EC) has approved a combination therapy for the treatment of metastatic colorectal cancer. 

Braftovi (encorafenib) has been approved in combination with cetuximab and FOLOX for the first-time treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). 

The approval is based on the results from the Phase III BREAKWATER trial, which assessed the efficacy and safety of Braftovi in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab. 

The combination therapy led to a median progression-free survival of 12.8 months compared to 7.1 months with oxaliplatin-based chemotherapy with or without bevacizumab, and extended overall survival to 30.3 months compared to 15.1 months with oxaliplatin-based chemotherapy with or without bevacizumab. 

“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 BRAFV600E-mutant mCRC,” said Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre, the pharmaceutical lab that developed the treatment.  

“Today’s [22 June] 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.”