biotech / news / / Benzinga
Guardant Health Inc.’s Guardant360 CDx is a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) The accelerated approval for Braftovi was supported by data from Pfizer Inc.
The FDA approved Guardant360 CDx as the first liquid biopsy companion diagnostic for BRAF V600E-mutant mCRC.
KEY POINTS
- Guardant360 CDx is now FDA-approved for use in colorectal cancer, in addition to lung and breast cancer.
- The BREAKWATER Phase 3 trial showed encorafenib, cetuximab, and chemotherapy significantly outperformed standard care in mCRC.
- Guardant Health recently signed a multi-year collaboration with Merck to support oncology portfolio development using Guardant Infinity Smart.
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