Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)
February 22 2021 - 1:46PM
Business Wire
Companion diagnostic can help guide treatment decisions in cases
of NSCLC
Agilent Technologies Inc. (NYSE: A) today announced that the
U.S. Food and Drug Administration (FDA) has approved the company’s
PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with
non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now
be used as an aid in identifying NSCLC patients with tumor PD-L1
expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with
Libtayo® (cemiplimab-rwlc). This announcement underscores Agilent's
continuing commitment to the development of IHC-based diagnostics
for cancer therapy.
Lung cancer is the leading cause of cancer death in both men and
women in the United States, with NSCLC making up 85% of all lung
cancer cases.1,2 PD-L1 expression is a biomarker for response to
anti-PD-1 therapy in NSCLC; this expanded indication enables
pathologists to identify patients with advanced NSCLC who may be
eligible for treatment with Libtayo. Currently, PD-L1 IHC 22C3
pharmDx is the only companion diagnostic with FDA approval for this
use.
"Anti-PD-1 therapies, including Libtayo, continue to broaden the
potential for the treatment of patients across different cancer
types,” said Sam Raha, president of Agilent's Diagnostics and
Genomics Group. "With the FDA approval of PD-L1 IHC 22C3 pharmDx as
a companion diagnostic for treatment with Libtayo monotherapy in
advanced NSCLC, Agilent further strengthens its ability to elevate
pathologist confidence in reporting results to oncologists and
bolsters our role as a global pioneer in developing companion
diagnostics for targeted treatments."
Regeneron and Sanofi developed Libtayo and partnered with
Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1
expression in patients in the pivotal EMPOWER-Lung 1 clinical
trial.3
PD-1 immunotherapies such as Libtayo offer new treatment options
for patients with advanced NSCLC, for whom the 60-month overall
survival rate is 0–10% in patients with stage IVA–IVB disease.2
Libtayo is a fully-human monoclonal antibody targeting the
immune checkpoint receptor PD-1 on T-cells. By binding to PD-1,
Libtayo has been shown to block cancer cells from using the PD-1
pathway to suppress T-cell activation.3
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets, delivering
insight and innovation toward improving the quality of life.
Agilent instruments, software, services, solutions, and people
provide trusted answers to customers' most challenging questions.
The company generated revenue of $5.34 billion in fiscal 2020 and
employs 16,400 people worldwide. Information about Agilent is
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References: 1. Lung and Bronchus Cancer – Cancer
Stat Facts. https://seer.cancer.gov/statfacts/html/lungb.html
(accessed Nov 24, 2020). 2. “Non–Small Cell Lung Cancer:
Epidemiology, Screening, Diagnosis, and Treatment.”
https://www.mayoclinicproceedings.org/article/S0025-6196(19)30070-9/fulltext
(accessed Nov 24 2020). 3. Libtayo [package insert].
Tarrytown, NY: Regeneron Pharmaceuticals Inc.; 2021.
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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