Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer with encorafenib-based treatment
Guardant Health today announced that the US FDA has approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Braftovi (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.
