Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer
(Thomson Reuters ONE) -
Validated Assay Offers New Option for Patients
GLOSTRUP, Denmark, Oct. 5, 2015 - Dako, an Agilent Technologies company and a
worldwide provider of cancer diagnostics, announced Oct. 2 that 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.
On Oct. 2, the FDA 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.
EDITORIAL CONTACT: PRDK15004
Victoria Wadsworth-Hansen
+1 408 553 2005 or
+45 2933 6980
victoria.wadsworth-hansen(at)agilent.com
This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Dako Denmark A/S via GlobeNewswire
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