Shots:
- The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT
- Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic test, enabled rapid ctDNA analysis for treatment selection & resistance monitoring
- Additionally, encorafenib + cetuximab & mFOLFOX6 significantly improved ORR, PFS & OS vs SoC in previously untreated BRAF-mutant mCRC, highlighting the value of early genomic testing
Ref: Businesswire | Image: Guardant Health | Press Release
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