The liquid biopsy test identifies patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from encorafenib combination therapy.
The US Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Braftovi (encorafenib) in combination with cetuximab and chemotherapy.
The 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. 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.
This marks the 25th companion diagnostic indication for Guardant360 CDx across multiple tumor types and expands the platform’s role in guiding targeted therapy across solid tumors. The test now has FDA-cleared companion diagnostic claims across lung cancer, breast cancer, and colorectal cancer.
“This latest approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx in enabling precision therapy selection for patients with diverse, hard-to-treat tumors including aggressive colorectal cancer,” says Helmy Eltoukhy, Guardant Health chairman and co-CEO, in a release.
Addressing High-Risk Patient Population
Colorectal cancer remains the second-leading cause of cancer-related deaths in the US, with BRAF V600E mutations present in approximately 8% to 10% of metastatic colorectal cancer cases. The mutation represents a molecularly distinct and aggressive subtype of metastatic colorectal cancer with poor prognosis and limited treatment options.
Guardant360 CDx uses a blood draw to detect BRAF V600E and other clinically relevant genetic alterations, helping clinicians quickly identify patients eligible for FDA-approved treatments. The test enables timely treatment decisions when tumor tissue is unavailable, insufficient, or when rapid initiation of therapy is clinically necessary.
The BREAKWATER trial demonstrated significant improvement in overall response rate, progression-free survival, and overall survival for patients treated with encorafenib plus cetuximab with mFOLFOX6 chemotherapy. Guardant360 CDx enabled rapid circulating tumor DNA analysis for treatment selection and resistance monitoring during the study.
“With multiple FDA-cleared companion diagnostic claims across lung and breast cancer, and now colorectal cancer, and the ability to profile tumor genomics from a simple blood draw, Guardant360 CDx is helping clinicians match patients to the right targeted therapies faster and more effectively,” says Eltoukhy in a release.
Guardant360 CDx is the FDA-approved liquid biopsy for genomic profiling that detects multiple genomic alterations across all solid tumors. The test is now approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.
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