3 June 2020 - European approval is based on the Phase 3 BEACON CRC trial that demonstrated a significant improvement in overall survival of patients treated with Braftovi in combination with cetuximab.
Pierre Fabre today announced that the European Commission has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.
This approval is based on data from the Phase 3 BEACON CRC trial. The EC decision is applicable to all 27 EU member states plus Iceland, Liechtenstein, Norway and the United Kingdom.