Health
Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
PALO ALTO, Calif., January 22, 2026--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved 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 in accordance with the approved product labeling.
About this update from Guardant Health, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1806,"height":619,"url":"https://media.zenfs.com/en/business-wire.com/873e977ad3042b364c8068e4501aabe7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/t45klOhTb.orSfd8kdrzrQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTMyOTtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/873e977ad3042b364c8068e4501aabe7","width":960,"height":329},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/C7M3c58fIp.YS6WHUtxuhA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTI0MDA7aD04MjI7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/873e977ad3042b364c8068e4501aabe7","width":1200,"height":411}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"First FDA-approved CDx for Guardant360 CDx in colorectal cancer further expands its role in guiding targeted therapy across solid tumors","length":136,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant mCRC with encorafenib-based treatment","length":148,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":284,"olType":false},{"type":"text","content":"PALO ALTO, Calif., January 22, 2026--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved 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 in accordance with the approved product labeling.","length":485,"tagName":"p"},{"type":"text","content":"The accelerated approval was supported by data from Pfizer’s Phase 3 BREAKWATER trial, which evaluated encorafenib-based regimens in previously untreated patients with BRAF-mutated metastatic colorectal cancer mCRC. The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free and overall survival compared with standard care, underscoring the importance of early genomic testing to guide targeted therapy.","length":500,"tagName":"p"},{"type":"text","content"...