Dako, an Agilent Technologies Company, Announces FDA Approval of New Test for Lung Cancer Patients
October 09 2015 - 3:21PM
Business Wire
First Complementary Diagnostic Approved to
Support Use of Bristol-Myers Squibb’s OPDIVO for
Non-Squamous Non-Small Cell Lung Cancer
Dako, an Agilent Technologies company and a worldwide provider
of cancer diagnostics, today announced the U.S. Food and Drug
Administration has approved a new test that can identify PD-L1
expression levels on the surface of non-small cell lung cancer
tumor cells and provide information on the survival benefit with
OPDIVO® (nivolumab) for patients with non-squamous NSCLC.
Dako developed the diagnostic, known as PD-L1 IHC 28-8 pharmDx,
through a collaboration with Bristol-Myers Squibb, the maker of
OPDIVO®, an immuno-oncology therapy approved by the FDA for the
treatment of all patients with previously treated NSCLC. The
diagnostic was used to assess PD-L1 expression in the Phase 3
CheckMate 057 trial, in which OPDIVO® demonstrated superior overall
survival in patients with previously treated metastatic
non-squamous NSCLC compared to chemotherapy. The FDA today expanded
the indication for OPDIVO® to include previously treated
non-squamous NSCLC in addition to the squamous NSCLC
indication.
Lung cancer is the leading cause of cancer-related deaths
worldwide. Historically, the one-year overall survival in the
second-line treatment of NSCLC has been about 26 percent.
“Immuno-oncology is an important area within cancer treatment,
and we are excited about Agilent’s involvement in these
advancements and the potential PD-L1 IHC 28-8 pharmDx has in
helping to provide information to oncologists considering OPDIVO
for patients with non-squamous non-small cell lung cancer,” said
Jacob Thaysen, president of Agilent’s Diagnostics and Genomics
Group.
“We are proud to announce the recent FDA approval of OPDIVO
based upon overall survival in an expanded indication for all
appropriate patients with previously treated metastatic non-small
cell lung cancer,” added Michael Giordano, senior vice president
and head of Development, Oncology, at Bristol-Myers Squibb. “Our
collaboration with Dako underscores our leadership in cancer
innovation and our commitment to advancing research evaluating the
potential role of PD-L1 in multiple tumor types.”
PD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay
approved to assess the survival benefit associated with OPDIVO®.
PD-L1 testing is not required for the use of OPDIVO®, but it may
provide additional information for physicians and inform patient
dialogue.
Dako is a worldwide leader in partnering with pharmaceutical
companies to develop immunohistochemical-based diagnostics for
cancer therapy.
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. The company generated revenues of $4.0 billion in fiscal
2014 and employs about 12,000 people worldwide. Agilent marks its
50th anniversary in analytical instrumentation this year. 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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EDITORIAL CONTACT:Agilent Technologies Inc.Victoria
Wadsworth-Hansen, +1
408-553-2005victoria.wadsworth-hansen@agilent.com
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