Agilent Companion Diagnostic Gains Expanded FDA Approval in Cervical Cancer
13 June 2018 - 6:47AM
Business Wire
PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify
cervical cancer patients for treatment with KEYTRUDA®
(pembrolizumab)
Agilent Technologies Inc. (NYSE: A) today announced that the
U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1
IHC 22C3 pharmDx assay for expanded use.
Physicians in the United States can now gain valuable
information to help them identify cervical cancer patients who are
most likely to benefit from treatment with KEYTRUDA, an anti-PD1
immunotherapy manufactured by Merck (known as MSD outside the
United States and Canada).
PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test
for determining PD-L1 expression in cervical cancer and is the
first FDA-approved companion diagnostic to identify patients with
cervical cancer for treatment with KEYTRUDA. This follows an
initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell
lung cancer and a subsequent expanded approval to include gastric
or gastroesophageal junction adenocarcinoma.
“PD-L1 is a critical biomarker for identifying patients who are
likely to derive benefit from anti-PD-1 immunotherapy, and with an
increasingly complex marketplace, pathologists look to Agilent as
the clear leader to provide accurate and reliable PD-L1 testing,”
said Sam Raha, president of Agilent's Diagnostics and Genomics
Group. “This expansion of use for the Dako PD-L1 IHC 22C3 pharmDx
assay gives patients with cervical cancer the possibility of having
their tumor sample tested for PD-L1 expression, and determining
eligibility for treatment with KEYTRUDA.”
Cervical cancer is the third most common gynecologic cancer in
the United States, with 13,000 cases expected to be diagnosed this
year alone. The overall survival rate has not improved in the past
40 years, despite advancements in prevention and early detection.
Cervical cancer patients previously had few treatment options other
than highly toxic chemotherapy.
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, with
their therapeutic value being demonstrated across a growing list of
cancer types.
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
partnership with Merck & Co.
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 $4.47 billion in fiscal 2017 and employs 14,200 people
worldwide. Information about Agilent is available at
www.agilent.com.
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Agilent TechnologiesVictoria Wadsworth-Hansen,
+1-408-553-2005+45 2933
6980victoria.wadsworth-hansen@agilent.com
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