Pierre Fabre gets EC nod for Braftovi plus cetuximab to treat BRAFV600E-mutant mCRC

Pierre Fabre has secured approval from the European Commission (EC) for Braftovi (encorafenib) plus cetuximab (Erbitux) to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.

The approval, which is based on results from the phase 3 BEACON CRC trial, enables to market Braftovi plus cetuximab in 27 EU member states, as well as Iceland, Liechtenstein, Norway and the UK.

Braftovi is an oral small-molecule BRAF kinase inhibitor, which targets a crucial enzyme in the MAPK signalling pathway (RAS-RAF-MEK-ERK).

According to Pierre Fabre, the BEACON CRC trial demonstrated that Braftovi plus cetuximab significantly improved overall survival (OS) in patients with BRAFV600E-mutant mCRC and reduced the risk of death by 40%, compared with the cetuximab plus irinotecan-containing regimen (control) arm.

In April, Pierre Fabre’s partner Pfizer announced that the US Food and Drug Administration (FDA) approved Braftovi plus cetuximab to treat adult patients with mCRC with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. Pfizer holds exclusive rights to market Braftovi in the US and Canada.

BEACON CRC is a randomised, open-label and global study designed to assess the efficacy and safety of Braftovi plus binimetinib in combination with cetuximab in patients with BRAFV600E-mutant mCRC whose disease has progressed after one or two prior regimens.

It is claimed to be the first and only Phase 3 trial designed to test a BRAF combination targeted therapy in BRAFV600E-mutant mCRC.

The 665 patient-trial was carried out at more than 200 investigational sites in North America, South America, Europe and the Asia Pacific region. Pierre Fabre, Pfizer and Merck and Ono Pharmaceutical supported the trial.

In September 2018, the Braftovi plus Mektovi secured EC approval to treat adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.

Pierre Fabre medical care business unit CEO Jean-Luc Lowinski said: “We are extremely pleased that patients will now have access, for the very first time, to a targeted therapy specifically for BRAFV600E-mutant mCRC.

“Today’s approval is a testament to our long-term commitment to advancing care for patients living with difficult-to-treat cancers and to delivering precision medicine. We will now work tirelessly to bring this new treatment option to patients in Europe, as quickly as possible.”