Validated Assay Offers New Option for Patients
Dako, an Agilent Technologies company and a worldwide provider of cancer
diagnostics, today announced the U.S. Food and Drug Administration (FDA)
approval of a new companion diagnostic assay that can reveal whether a
patient with advanced non-small cell lung cancer (NSCLC) is likely to
respond to a new form of treatment. The approval of PD-L1 IHC 22C3
pharmDx strengthens Dako’s portfolio of companion diagnostics and the
company’s leadership position in developing and commercializing
companion diagnostic products.
Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co.,
Inc. (known as MSD outside the U.S. and Canada), maker of the anti-PD-1
therapy KEYTRUDA® (pembrolizumab). KEYTRUDA is approved by
the FDA to treat patients with metastatic NSCLC whose tumors express
PD-L1 as determined by the companion diagnostic assay and who have
disease progression on or after platinum-containing chemotherapy.
KEYTRUDA is an immunotherapy that blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby helping the immune system do
what it is meant to do: help detect and fight cancer cells. KEYTRUDA can
also cause the immune system to attack normal organs and tissues.
The FDA today approved PD-L1 IHC 22C3 pharmDx for use in the United
States. Dako hopes to gain regulatory approval for the new diagnostic in
Canada, Europe and other jurisdictions next year.
Lung cancer is the leading cause of cancer-related death worldwide, and
NSCLC accounts for 80 percent of all lung cancers. PD-L1 IHC 22C3
pharmDx is the first and only companion diagnostic assay that has been
validated and approved to identify NSCLC patients eligible for KEYTRUDA.
“Because individuals often respond differently to the same treatment,
scientists have been putting more emphasis on personalized medicine,
which is where PD-L1 IHC 22C3 pharmDx comes into play,” said Jacob
Thaysen, president of Agilent’s Diagnostics and Genomics Group. “This is
a new era in immunoncology, and we are particularly excited about
Agilent’s involvement in advancements in cancer treatment and the
potential PD-L1 IHC 22C3 pharmDx has in helping to identify patients
with non-small cell lung cancer who are most likely to benefit from
treatment with KEYTRUDA.”
“The approval of the first PD-L1 diagnostic has the potential to provide
information that will help guide treatment decisions for many patients,”
said Dr. Roger Dansey, senior vice president, Merck Research
Laboratories. “PD-L1 is an important new biomarker, and we look forward
to working with Dako to make PD-L1 testing a routine part of the
diagnosis and treatment of non-small cell lung cancer.”
About Agilent Technologies and Dako
Agilent Technologies Inc. (NYSE: A), a global leader in life sciences,
diagnostics and applied chemical markets, is the premier laboratory
partner for a better world. Agilent works with customers in more than
100 countries, providing instruments, software, services and consumables
for the entire laboratory workflow. Agilent generated revenues of $4.0
billion in fiscal 2014. The company employs about 12,000 people
worldwide. In 2012, Agilent acquired Dako, a well-known provider of
reagents, instruments, software and expertise to make accurate diagnoses
and determine the most effective treatment for cancer patients.
Information about Agilent is available at www.agilent.com and
information about Dako
products is available here.
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