Agilent Announces Expanded Use of Cancer Diagnostic in the United States
September 19 2017 - 9:00AM
Business Wire
Dako PD-L1 IHC 28-8 PharmDx Approved for Two New
Indications
Agilent Technologies Inc. (NYSE: A) today announced that the
U.S. Food and Drug Administration (FDA) has approved the cancer
diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of
urothelial carcinoma (UC) and of squamous cell carcinoma of the
head and neck (SCCHN).
The test had previously been approved for melanoma as well as
non-squamous, non-small-cell lung cancer (NSCLC). PD-L1 IHC 28-8
pharmDx, developed in collaboration with Bristol-Myers Squibb
(BMS), has a broad utility with more clinically validated tumor
indications than any other commercially produced PD-L1 assay
currently on the U.S. market.
The PDL1 IHC 28-8 pharmDx test enables physicians in the USA to
identify which patients with locally advanced or metastatic UC and
recurrent or metastatic SCCHN who have disease progression on or
after platinum-based chemotherapy would most likely benefit from
treatment with Opdivo® (nivolumab). Opdivo is an
immunotherapy developed by BMS and approved in these indications
regardless of PD-L1 status. While the test is not required for
treatment, with these latest indications, pathologists in the USA
now have access to a clinically validated complementary test to
determine tumor PD-L1 status, in patients with these difficult to
treat diseases.
SCCHN is the most common form of head and neck cancer. Data from
a pre-specified exploratory analysis of the CHECKMATE-141 clinical
trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC
28-8 pharmDx in SCCHN, may be associated with an enhanced survival
benefit for the patient from the use of Opdivo.
Urothelial carcinoma is the most common type of bladder cancer,
accounting for approximately 90% of diagnoses1. Data from a recent
clinical study CHECKMATE-275, showed that tumor PD-L1 expression
assessed by PD-L1 IHC 28-8 pharmDx may help inform which UC
patients are more likely to respond to Opdivo.
“I am delighted that this approval by the FDA enables our
products to help inform better patient selection for these very
distressing cancers,” said Jacob Thaysen, president of Agilent's
Diagnostics and Genomics Group. “Agilent’s Dako brand of innovative
pathology diagnostics seek to deliver results that pathologists can
trust. Our rigorous design process ensures that evidence is based
not only on analytical validation but also clinical validation by
inclusion in our partner’s clinical trials.”
Immunotherapies are designed to help an individual's immune
system detect and kill cancer cells. Because individual patients
often respond differently to the same treatment, scientists have
been focusing emphasis on personalized medicine, which is where
Agilent's Dako brand of diagnostics comes into play, providing
important information about the status of key biomarkers in
individual cancer patients.
Agilent is a worldwide leader in partnering with pharmaceutical
companies to develop diagnostics using both immunohistochemical and
genomic-based technologies for cancer therapy.
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 its
customers’ most challenging questions. The company generated
revenues of $4.20 billion in fiscal 2016 and employs about 13,000
people worldwide. Information about Agilent is available at
www.agilent.com.
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 Dako is available here.
1 Kaufman DS, Shipley W, Feldman AS. Bladder cancer. Lancet.
2009;374(9685):239-49.
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Agilent TechnologiesVictoria Wadsworth-Hansen, +1
408-553-2005victoria.wadsworth-hansen@agilent.com
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