Guardant360® CDx Receives FDA Approval as Companion Diagnostic for Janssen’s RYBREVANT™ (amivantamab-vmjw) for Use in Pa...
May 21 2021 - 3:14PM
Business Wire
Guardant Health blood test identifies patients with EGFR exon 20
insertion mutations who may benefit from targeted treatment with
RYBREVANT™ after progressing on or after platinum-based
chemotherapy
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
- CDC Centers for Disease Control and Prevention.
https://www.cdc.gov/cancer/dcpc/research/update-on-cancer-deaths/index.htm#:~:text=Lung%20cancer%20is%20the%20leading,24%25%20of%20all%20cancer%20deaths.
Accessed online May 18, 2021
- Cancer.net.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed online May 18, 2021.
- Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR
mutation in patients with non-small cell lung cancer: a systematic
review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
- Remon J, Hendriks LEL, Cardona AF, Besse B. EGFR exon 20
insertions in advanced non-small cell lung cancer: A new history
begins. Cancer Treat Rev. 2020;90:102105.
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version on businesswire.com: https://www.businesswire.com/news/home/20210521005484/en/
Investor Contact: Carrie Mendivil
investors@guardanthealth.com Media Contact: Anna Czene
press@guardanthealth.com Julie Johnson
julie.johnson@uncappedcommunications.com
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