Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small ...
October 24 2016 - 6:10PM
Business Wire
Untreated metastatic NSCLC patients with high PD-L1
expression can now be identified for treatment with
KEYTRUDA® (pembrolizumab) using PD-L1 IHC 22C3
pharmDx
In addition, the labeling update identifies a broader range
of previously treated metastatic NSCLC patients with PD-L1
expression for treatment with KEYTRUDA
Agilent Technologies Inc. (NYSE: A) today announced that its
Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by
the U.S. Food and Drug Administration for use in determining PD-L1
expression status to inform treatment in metastatic non-small cell
lung cancer (NSCLC) with KEYTRUDA® (pembrolizumab). This expanded
intended use now allows the PD-L1 IHC 22C3 pharmDx test to detect
PD-L1 expression in a broader range of patients – those with a
PD-L1 tumor proportion score (TPS) of 1 percent or more.
The FDA also announced on Oct. 24 that KEYTRUDA is now approved
for the first-line treatment of metastatic NSCLC patients whose
tumors express high levels of PD-L1 (TPS of 50 percent or more) or
for previously treated metastatic NSCLC patients whose tumors
express PD-L1 (TPS of 1 percent or more).
This updated approval of PD-L1 IHC 22C3 pharmDx means that the
assay can be used to identify previously untreated patients with
metastatic NSCLC expressing high levels of PD-L1 for treatment with
KEYTRUDA. Prior to this, chemotherapy was the standard first-line
treatment for most NSCLC patients. The labeling update also means
that more patients in the second-line or later treatment setting –
including patients with levels of PD-L1 expression of 1 percent or
more – can also be identified for treatment with KEYTRUDA.
“This expanded intended use for our FDA-approved PD-L1 IHC 22C3
pharmDx assay is a step towards providing first-line metastatic
NSCLC patients with immunotherapy as an option. PD-L1 IHC 22C3
pharmDx allows pathologists to confidently determine, and report
PD-L1 expression status for a patient’s tumor. This critical
diagnostic information informs oncologists’ treatment decisions
around KEYTRUDA,” said Jacob Thaysen, president of Agilent's
Diagnostics and Genomics Group. “Pathologists recognize the need
for approved and validated tests, and our companion diagnostic
gives them a highly accurate tool to inform oncologists on PD-L1
expression.”
“PD-L1 is an important biomarker for use in identifying those
patients with metastatic non-small cell lung cancer who are most
likely to benefit from treatment with KEYTRUDA,” said
Dr. Roger Dansey, senior vice president and therapeutic area
head, oncology late-stage development, Merck Research
Laboratories. “With the approval of both the medicine and companion
diagnostic to include first-line evaluation and treatment, and the
broadening of the Dako PD-L1 IHC 22C3 pharmDx label in the
second-line and later treatment setting, we now have the
opportunity to help many more patients with this devastating
disease.”
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 was developed in partnership with Merck
& Co., Inc. (known as MSD outside the U.S. and Canada), maker
of the anti-PD-1 therapy, KEYTRUDA.
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.
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 $4.04 billion in fiscal
2015 and employs about 12,000 people worldwide.
In 2012, Agilent acquired Dako, a well-known provider of
reagents, instruments, software and expertise. Agilent’s Dako
pathology solutions help pathologists make accurate diagnoses and
determine the most effective treatment for cancer patients.
Information about Agilent is available at www.agilent.com, and
information about Agilent’s Dako pathology solutions 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 TechnologiesVictoria Wadsworth-Hansen, +1
408-553-2005+45 29336980victoria.wadsworth-hansen@agilent.com
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