The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi (encorafenib) for the treatment of metastatic colorectal cancer (mCRC) with BRAFV600E mutations.

The recommendation covers the use of the therapy in combination with cetuximab and Folfox as a first-line treatment option for adult patients with BRAFV600E-mutant mCRC.

This represents a potential advance for initial therapy of BRAFV600E-mutant mCRC in Europe.

The CHMP opinion is based on results from the Phase III BREAKWATER trial.

The study demonstrated that encorafenib, in combination with cetuximab and Folfox, led to statistically significant improvements in the primary endpoints of objective response rate (ORR) and progression-free survival (PFS).

Furthermore, a substantial overall survival (OS) benefit was observed, reducing the risk of death by 51% compared to chemotherapy, with or without bevacizumab.

Median progression-free survival was 12.8 months compared to 7.1 months for those treated with chemotherapy with or without bevacizumab.

The regimen also showed a significant improvement in objective response rate in the primary analysis set.

The European Commission (EC) is expected to make its marketing authorisation decision later in the year.

If approved, this combination would become the first and only B-Raf proto-oncogene, serine/threonine kinase (BRAF)-targeted therapy available for first-line treatment of adult BRAFV600E-mutant mCRC patients in the European Union.

Pierre Fabre Laboratories CEO Eric Ducournau said: “Today's positive CHMP opinion marks an important step towards a targeted approach for patients with BRAFV600E-mutant metastatic colorectal cancer.

“This milestone reflects Pierre Fabre Laboratories' 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.”