Agilent PD-L1 IHC 28-8 pharmDx Receives CE-IVD Mark as a Companion Diagnostic Test in Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
October 21 2021 - 08:31AM
Business Wire
Agilent Technologies Inc. (NYSE: A) today announced it has
received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to
guide options for the first-line treatment of adult patients with
HER2-negative advanced or metastatic gastric, gastroesophageal
junction, or esophageal cancers.
Gastric (stomach) cancer is the fifth most common cancer and the
fourth leading cause of cancer death worldwide, with over 1,000,000
new cases and approximately 770,000 deaths in 2020.1 Esophageal
cancer is the seventh most common cancer and the sixth leading
cause of death from cancer worldwide, with approximately 600,000
new cases and over 540,000 deaths in 2020. 1 Together with cancers
of the gastroesophageal junction, they constitute an important –
and growing – global health concern.
PD-L1 is a critical biomarker for response to anti-PD-1
therapies, including the immunotherapeutic agent OPDIVO®
(nivolumab). When used in conjunction with the PD-L1 IHC 28-8
pharmDx as a companion test, treatment with Opdivo® in combination
with chemotherapy provides the first and only PD-1-directed
treatment to demonstrate superior overall survival (OS) and
progression-free survival (PFS) when compared to chemotherapy alone
in patients with advanced or metastatic gastric, gastroesophageal
junction, or esophageal adenocarcinoma whose tumors express PD-L1
with a combined positive score (CPS) ≥ 5.
"The added indication of PD-L1 IHC 28-8 pharmDx will give
physicians in Europe important information to inform first-line
treatment decisions for patients with these common and potentially
deadly cancers," said Sam Raha, president of the Agilent’s
Diagnostics and Genomics Group. "Agilent values opportunities such
as this to partner with pharmaceutical companies in the development
of clinically relevant IHC-based or NGS-based diagnostics that
enhance confidence in targeted cancer therapy."
This approval builds on Agilent's previous successes in
expanding the applicability of PD-L1 IHC tests and marks the latest
milestone in their ongoing commitment to drug/diagnostic
co-development.
About Agilent Technologies
Agilent is a leader in life sciences, diagnostics, and applied
chemical markets, delivering innovative technology solutions that
provide trusted answers to researchers’ most challenging scientific
questions. The company generated revenue of $5.34 billion in fiscal
year 2020 and employs 16,400 people worldwide. Information about
Agilent is available at www.agilent.com. To receive the latest
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References:
1. Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M.,
Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global
cancer statistics 2020: Globocan estimates of incidence and
mortality worldwide for 36 cancers in 185 countries. CA: A Cancer
Journal for Clinicians, 71(3), 209–249.
https://doi.org/10.3322/caac.21660
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
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