Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic
May 18 2020 - 8:00AM
Business Wire
Assay will help guide treatment decisions in cases of non-small
cell lung cancer
Agilent Technologies Inc. (NYSE: A) today announced that the
U.S. Food and Drug Administration has approved the company’s PD-L1
IHC 28-8 pharmDx for expanded use in non-small cell lung cancer
(NSCLC).
Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx
assay as an aid in identifying patients with metastatic NSCLC for
treatment with the dual immunotherapy combination of Opdivo
(nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers
Squibb. Based on the results of the Phase 3 CheckMate -227 clinical
trial, Opdivo in combination with Yervoy was approved as first-line
treatment for patients with metastatic NSCLC whose tumors express
PD-L1 (≥1%) as determined by an FDA-approved test.
“The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians
in the USA critical information to inform first-line treatment
decisions for patients with metastatic non-small cell lung cancer,”
said Sam Raha, president of Agilent's Diagnostics and Genomics
Group.
Agilent developed PD-L1 IHC 28-8 pharmDx in 2016 through a
collaboration with Bristol Myers Squibb, and it has been previously
approved as a complementary in vitro diagnostic for non-squamous
non-small cell lung cancer, as well as other forms of cancer,
including, squamous cell carcinoma of the head and neck, and
urothelial carcinoma.
Lung cancer is the most commonly diagnosed cancer worldwide
across both sexes, causing 18.4% of all cancer deaths, with an
estimated two million new cases reported in 2018. NSCLC accounts
for 80%–90% of lung cancers, and 75% of NSCLC patients are
diagnosed in the advanced stage.
Agilent is a worldwide leader in the development and
commercialization of precision medicine diagnostics in
collaboration with biopharmaceutical companies.
Opdivo® and Yervoy® are registered trademarks of Bristol-Myers
Squibb Company.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets. Now in its
20th year as an independent company 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 $5.16 billion in fiscal 2019 and
employs 16,300 people worldwide. Information about Agilent is
available at www.agilent.com. To receive the latest Agilent news,
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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