March 2026—The Food and Drug Administration has approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with encorafenib (Braftovi, Pfizer) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.
The accelerated approval was supported by data from Pfizer’s phase three Breakwater trial, which evaluated encorafenib-based regimens in previously untreated patients with BRAF-mutated metastatic colorectal cancer. The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved the objective response rate and progression-free and overall survival compared with standard care.
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