Agilent Companion Diagnostic Gains Expanded FDA Approval in Cervical Cancer
Business Wire 12-Jun-2018 4:47 PM
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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