Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Esophageal Squamous Cell Carcinoma
05 Abril 2022 - 9:15AM
Business Wire
Agilent Technologies Inc. (NYSE: A) today announced it has
expanded CE-IVD marking in the European Union for its PD-L1 IHC
28-8 pharmDx as an aid in identifying esophageal squamous cell
carcinoma patients for treatment with Bristol Myers Squibb’s
PD-1-targeted immunotherapeutic OPDIVO® (nivolumab), in combination
with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® in
combination with YERVOY® (ipilimumab). These combined treatments
provide new hope for patients diagnosed with these cancers.
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.
The two most common types of esophageal cancer are squamous cell
carcinoma and adenocarcinoma, which account for approximately 85%
and 15% of all esophageal cancers, respectively, though esophageal
tumor histology can vary by region and country.
PD-L1 is a critical biomarker for response to anti-PD-1
therapies, including the immunotherapeutic agent OPDIVO® based on
the Phase 3 CheckMate-648 trial results. When used in conjunction
with PD-L1 IHC 28-8 pharmDx as a companion test, first-line
treatment with OPDIVO® in combination with chemotherapy or in
combination with YERVOY® provides PD-1-directed treatment to
demonstrate superior overall survival when compared to chemotherapy
alone in patients with unresectable advanced, recurrent, or
metastatic previously untreated esophageal squamous cell carcinoma
with tumor cell PD-L1 expression ≥ 1%.
“With the CE marking of expanded use in Europe of our PD-L1 IHC
28-8 pharmDx assay, Agilent enables pathologists the increased
capability to identify patients with ESCC for first-line treatment
with OPDIVO® in combination with chemotherapy or YERVOY®
(ipilimumab)," said Sam Raha, president of Agilent's Diagnostics
and Genomics Group. “We greatly value our relationship with Bristol
Myers Squibb, and are committed to continuing developing and
commercializing market-leading companion diagnostic products.”
Agilent is the worldwide leader in partnering with
pharmaceutical companies to develop IHC-based diagnostics for
targeted cancer therapy. With the expansion of PD-L1 IHC 28-8
pharmDx, Agilent continues to set the standard and lead with
innovation, quality, and ease of implementation—furthering their
ongoing commitment to fight cancer and enable new discoveries.
References
1. Bray, F.; Ferlay, J.; Soerjomataram, I.; Siegel, R.; Torre,
L.; Jemal, A. Global cancer statistics 2018: GLOBOCAN estimates of
incidence and mortality worldwide for 36 cancers in 185 countries.
CA A Cancer J. Clin. 2018, 68, 394–424.
https://doi.org/10.3322/caac.21492
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the
life sciences, diagnostics, and applied chemical markets,
delivering insight and innovation that advance the quality of life.
Agilent’s full range of solutions includes instruments, software,
services, and expertise that provide trusted answers to our
customers' most challenging questions. The company generated
revenue of $6.32 billion in fiscal 2021 and employs 17,000 people
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Media Contact Naomi Goumillout Agilent Technologies
+1.781.266.2819 naomi.goumillout@agilent.com
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