Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

Original from: Guardant Health

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.

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.

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 tissue is unavailable, insufficient, or when rapid initiation of therapy is clinically necessary.

“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,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “With multiple FDA-cleared companion diagnostic claims across lung and breast cancer, and now colorectal cancer, and the ability to comprehensively profile tumor genomics from a simple blood draw, Guardant360 CDx is helping clinicians match patients to the right targeted therapies faster and more effectively.”

Key highlights of the BREAKWATER trial include:

- Demonstrated significant improvement in overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) for patients treated with encorafenib plus cetuximab with mFOLFOX6 chemotherapy.

- Guardant360 CDx enabled rapid ctDNA analysis for treatment selection and resistance monitoring.

- The study supports the importance of early, comprehensive genomic profiling to improve outcomes in mCRC.

Colorectal cancer remains the second-leading cause of cancer-related deaths in the U.S., with BRAF V600E mutations present in approximately 8 to 10 percent of mCRC cases.1 The mutation is a molecularly distinct and aggressive subtype of mCRC with poor prognosis and limited treatment options. Early identification of this mutation is critical to guiding patients to more effective, targeted therapies. Guardant360 CDx offers a convenient and accessible method for detecting this actionable biomarker, especially when tissue samples are unavailable or inadequate for testing.

This latest FDA approval for Guardant 360 CDx marks the 25th companion diagnostic indication across multiple tumor types and builds on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

Source: Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer