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FDA Approves Guardant Health's Blood Test To Guide Treatment For Advanced Colorectal Cancer

On Thursday, the U.S. Food and Drug Administration (FDA) approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with Braftovi (encorafenib) in combination with cetuximab and chemotherapy.

The accelerated approval for Braftovi was supported by data from Pfizer Inc.’s (NYSE:PFE) Phase 3 BREAKWATER trial.

Data

The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free survival, and overall survival compared with standard care.

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling.

It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and now colorectal cancer.

Guardant360 CDx expands access to non-invasive genomic testing for this high-risk patient population.

Using a simple blood draw to detect BRAF V600E and other clinically relevant genetic alterations, the test helps clinicians quickly identify patients eligible for FDA-approved treatments, enabling timely treatment decisions when tumor ...