Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer
October 02 2015 - 3:22PM
Business Wire
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.
NOTE TO EDITORS: Further technology, corporate citizenship and
executive news is available at www.agilent.com/go/news.
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Agilent Technologies Inc.Victoria Wadsworth-Hansen,
+1-408-553-2005victoria.wadsworth-hansen@agilent.com
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