Agilent Receives Approval for First PD-L1 Companion Diagnostic in China
October 02 2019 - 10:39AM
Business Wire
Agilent Technologies Inc. (NYSE: A) today announced that the
National Medical Products Administration (NMPA, formerly the China
Food and Drug Administration) has approved its PD-L1 IHC 22C3
pharmDx assay for use in China.
The assay is now approved as a companion diagnostic to identify
patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score
[TPS] >1%) for first-line treatment
with single-agent KEYTRUDA, an anti-PD-1 therapy manufactured by
Merck & Co., Inc. Kenilworth, NJ, U.S.A.
Lung cancer accounts for 20% of all cancer deaths in China and
is the leading cause of cancer death there1. NMPA approved the
assay to identify advanced NSCLC patients whose tumors express
PD-L1 Tumor Proportion Score (TPS) ≥ 1% for first-line treatment
with KEYTRUDA monotherapy. KEYTRUDA, as monotherapy, recently
received NMPA approval for first-line treatment of patients with
locally advanced or metastatic NSCLC whose tumors express PD-L1 TPS
≥ 1% as determined by a validated test.
KEYTRUDA is a humanized monoclonal antibody that increases the
ability of the body's immune system to help detect and fight tumor
cells. KEYTRUDA blocks the interaction between PD-1 and its
ligands, PD-L1, and PD-L2, thereby activating T lymphocytes, which
may affect both tumor cells and healthy cells. KEYTRUDA and other
targeted immunotherapies are revolutionizing cancer treatment, and
their therapeutic value is being demonstrated in NSCLC.
“Pathologists in China recognize the need for validated tests,
and our companion diagnostic gives them a highly accurate tool to
inform oncologists on PD-L1 expression for metastatic NSCLC
patients," said Sam Raha, president of Agilent’s Diagnostics and
Genomics Group. “With this approval, Agilent is excited to be able
to offer the first PD-L1 CDx in the Chinese market.”
PD-L1 IHC 22C3 pharmDx is the first and only NMPA-approved
companion diagnostic that has been clinically validated to aid in
the identification of NSCLC patients for treatment with
KEYTRUDA.
Because individuals often respond differently to the same
treatment, scientists have been putting more emphasis on
personalized medicine, which is where assays such as PD-L1 IHC 22C3
pharmDx come into play.
Agilent is a worldwide leader in partnering with pharmaceutical
companies to develop immunohistochemical-based diagnostics for
cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in
collaboration with Merck & Co.
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6312841/
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics and applied chemical markets. With more than
50 years of insight and innovation, Agilent instruments, software,
services, solutions, and people provide trusted answers to
customers' most challenging questions. The company generated
revenues of $4.91 billion in fiscal 2018 and employs 15,500 people
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China Contact Kirna Liu Manager, China Public Relations
Agilent Technologies, Inc. +86 10 6439 7889
kirna_liu@agilent.com
Global Contact Victoria Wadsworth-Hansen Global Director
Public Relations Agilent Technologies +1 408 553 2005 +45 2933 6980
victoria.wadsworth-hansen@agilent.com
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