Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Cervical Cancer
10 Maio 2022 - 4:50PM
Business Wire
Agilent Technologies Inc. (NYSE: A) today announced that its
PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use
in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in
identifying cervical cancer patients for whom treatment with
KEYTRUDA® (pembrolizumab) may be appropriate.1 KEYTRUDA is an
anti-PD-1 therapy developed by Merck (known as MSD outside the U.S.
and Canada). In Europe, KEYTRUDA, in combination with chemotherapy
with or without bevacizumab, is indicated for the treatment of
persistent, recurrent, or metastatic cervical cancer in adults
whose tumors express PD-L1 [Combined Positive Score (CPS) ≥
1].2
PD-L1 expression is a critical biomarker for response to
anti-PD-1 therapies such as KEYTRUDA whose therapeutic value is
being demonstrated across a growing list of cancer types. Globally,
cervical cancer is the fourth most common cancer among women,3 with
approximately 30,447 new cases diagnosed in Europe in 2020.4
Sam Raha, president of Agilent’s Diagnostics and Genomics Group,
discussed the impact of the updated labeling. “PD-1/PD-L1-targeted
immunotherapies such as KEYTRUDA have become important cancer
treatment options for a growing number of patients. With this
European indication expansion of PD-L1 IHC 22C3 pharmDx into
cervical cancer, pathologists have access to reliable diagnostic
results, supporting even more cancer patients who could benefit
from targeted therapies.”
Currently, PD-L1 IHC 22C3 pharmDx is the only CE-IVD marked
companion diagnostic indicated as an aid in identifying cervical
cancer patients with PD-L1 CPS ≥ 1 for treatment with KEYTRUDA.
This indication expansion extends the scope of patients who can be
tested to determine eligibility for KEYTRUDA, and further
strengthens Agilent's leadership position as a partner in the
development of IHC-based diagnostics for targeted cancer
therapies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara,
CA: Agilent Technologies, Inc. (2022). 2. Keytruda [Summary of
Product Characteristics]. European Medicines Agency (2022). 3. WHO.
Cervical cancer, Key facts.
www.who.int/news-room/fact-sheets/detail/cervical-cancer (accessed
May 09, 2022). 4. European Cancer Information System (ECIS),
European Commission. Cervical cancer burden in EU-27.
https://ecis.jrc.ec.europa.eu/pdf/factsheets/cervical_cancer_en-Nov_2021.pdf
(accessed May 09, 2022).
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
worldwide. Information about Agilent is available at
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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