FDA grants traditional approval to encorafenib for CRC with BRAF V600E mutation

The Food and Drug Administration announced it has granted traditional approval to encorafenib, or Braftovi, from Array BioPharma, a subsidiary of Pfizer (PFE), in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024, the FDA noted.