Guardant360® CDx Receives FDA Approval as Companion Diagnostic for Janssen’s RYBREVANT™ (amivantamab-vmjw) for Use in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Rhea-AI Summary

Guardant Health announces FDA approval for the Guardant360^®CDx liquid biopsy test, the first companion diagnostic for Janssen Biotech’s RYBREVANT™. Designed for tumor mutation profiling in non-small cell lung cancer (NSCLC), it identifies patients with EGFR exon 20 insertion mutations who may benefit from targeted therapy after chemotherapy. With lung cancer being the leading cause of cancer death, this approval marks a significant advancement in treatment options. The Guardant360 CDx test offers rapid genomic results from a blood draw, enhancing oncologists' ability to personalize treatment for patients.

Positive

• FDA approval of Guardant360 CDx as the first companion diagnostic for RYBREVANT™, expanding treatment options for NSCLC patients.
• Rapid genomic profiling from a blood draw in seven days, improving clinical decision-making for oncologists.
• Guardant360 CDx aids in identifying a specific mutation type with no prior targeted therapeutic options.

Negative

• None.

Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360^® CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT™ (amivantamab-vmjw).

The Guardant360 CDx test will be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with RYBREVANT™ after progressing on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the U.S.¹, and NSCLC represents approximately 84 percent of all lung cancers.² EGFR mutations are present in about one-third of patients with NSCLC,³ and EGFR exon 20 insertion mutations are the third most prevalent mutation type.⁴ These mutations are highly resistant to chemotherapy and tyrosine kinase inhibitors (TKI)⁴, and until now, a targeted therapeutic has not existed.

“Today’s FDA approval of Guardant360 CDx as a companion diagnostic for RYBREVANT^™, the first targeted therapy to treat EGFR exon 20 mutations, is a key milestone for patients who, until now, have had limited treatment options,” said Helmy Eltoukhy, Guardant Health CEO. “We are proud to offer our Guardant360 CDx liquid biopsy blood test as a companion diagnostic so that patients may have access to comprehensive genomic profiling in order to see if they are eligible to receive this new treatment.”

For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360^®, Guardant360 CDx, and GuardantOMNI^® tests for advanced stage cancer patients, and Guardant Reveal^™ test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2020 and in its other reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2021. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

References

1. CDC Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/dcpc/research/update-on-cancer-deaths/index.htm#:~:text=Lung%20cancer%

FAQ

What is the significance of the FDA approval for Guardant Health's Guardant360 CDx?

The FDA approval allows Guardant360 CDx to be used as a companion diagnostic for RYBREVANT™, providing crucial mutation profiling for NSCLC patients, which enhances treatment personalization.

How does the Guardant360 CDx test benefit patients with NSCLC?

It identifies patients with EGFR exon 20 mutations, enabling targeted therapy options after standard chemotherapy, improving treatment outcomes.

What is the market potential of the Guardant360 CDx test?

This test addresses a significant unmet need in lung cancer treatment, potentially benefiting a large patient population with no existing targeted therapies.

How quickly can oncologists receive results from the Guardant360 CDx test?

Oncologists can obtain comprehensive genomic results within seven days from a simple blood draw.