Posted by Michael Wonder on 20 Dec 2024
FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation
20 December 2024 - Today, the FDA granted accelerated approval to encorafenib (Braftovi, Array BioPharma) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA approved test.
Efficacy was evaluated in BREAKWATER, an active-controlled, open-label, multi-centre trial.
