Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations
05 Setembro 2023 - 9:05AM
Business Wire
Blood test provides simple way for oncologists to test
patients with advanced NSCLC for genomic alterations that drive
selection of HER2-targeted therapy
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology
company, today announced the Japanese Ministry of Health, Labour
and Welfare (MHLW) has approved the Guardant360® CDx liquid biopsy
test as a companion diagnostic to select patients with unresectable
(inoperable) advanced or recurrent non-small cell lung cancer
(NSCLC) with HER2 (ERBB2) mutations that has progressed after
chemotherapy for treatment with ENHERTU® (trastuzumab
deruxtecan). ENHERTU is a specifically engineered HER2-directed
antibody drug conjugate developed by Daiichi Sankyo.
Mutations in the HER2 gene are responsible for approximately
2-4% of non-squamous NSCLC, which represents about 70% of NSCLC
cases.1,2 Overall, NSCLC accounts for about 80-85% of all lung
cancer,3 the leading cause of cancer death for men and women
worldwide.4 Guardant360 CDx is a next-generation sequencing-based
assay that detects genomic alterations using circulating tumor DNA
from blood. The approval for use of the test as a companion
diagnostic with ENHERTU in Japan is an expansion of the approval
received from the U.S. Food and Drug Administration (FDA) for the
same indication in August 2022.
“The ministry’s approval of Guardant360 CDx as a companion
diagnostic for ENHERTU is great news for patients with metastatic
non-small cell lung cancer with HER2 mutations,” said Helmy
Eltoukhy, Guardant Health chairman and co-CEO. “Oncologists in
Japan now have the first blood-based companion diagnostic to
determine if their patients are eligible to receive the first HER2
directed therapy approved to treat this specific condition. This is
another step forward in achieving Guardant Health’s mission to
conquer cancer globally.”
In March 2022, the MHLW approved the Guardant360 CDx test for
comprehensive genomic profiling in patients with advanced solid
tumors, and in July 2023, the test received national reimbursement
approval in Japan. The MHLW also previously approved the test as a
companion diagnostic to identify patients with microsatellite
instability-high (MSI-High) solid tumors who may benefit from
Keytruda® (pembrolizumab), patients with MSI-High advanced
colorectal cancer who may benefit from Opdivo® (nivolumab), and
patients with metastatic NSCLC who may benefit from treatment with
LUMAKRAS™ (sotorasib).
About Guardant360 CDx
For oncologists, the FDA-approved Guardant360 CDx test 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, Guardant360 has become widely accepted
for blood-based comprehensive genomic profiling with more than 400
peer-reviewed publications. It has been used by more than 12,000
oncologists, with more than 400,000 tests performed to date, and is
broadly covered by Medicare and private payers, insuring over 300
million people.
About Guardant Health
Guardant Health is a leading precision oncology company focused
on helping conquer cancer globally through use of its proprietary
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 Guardant360®, Guardant360 CDx,
Guardant360 TissueNext™, Guardant360 Response™, and
GuardantINFINITY™ tests for advanced stage cancer patients, and
Guardant Reveal™ for early-stage cancer patients. The Guardant
Health screening portfolio, including the Shield™ test, aims to
address the needs of individuals eligible for cancer screening. For
more information, visit guardanthealth.com and follow the company
on LinkedIn and Twitter.
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, 2022, and any
current and periodic reports filed with or furnished to the
Securities and Exchange Commission thereafter. 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
- N Engl J Med. 2022 Jan 20;386(3):241-251.
- J Thorac Dis. 2010 Dec; 2(4): 199–204.
- American Cancer Society.
https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html.
Accessed August 19, 2023.
- Cancer.net.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed August 19, 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20230905623334/en/
Investor Contact: investors@guardanthealth.com
Media Contact: Mike Weist press@guardanthealth.com +1 650
647 3643
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