Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC
April 16 2019 - 08:04PM
Business Wire
PD-L1 IHC 22C3 pharmDx Can Now Be Used to Identify a Broader
Range of NSCLC Patients for First-line Treatment With KEYTRUDA®
(pembrolizumab)
Agilent Technologies Inc. (NYSE: A) today announced that the
U.S. Food and Drug Administration has updated its approval of the
company’s PD-L1 IHC 22C3 pharmDx assay.
The assay can now be used as a companion diagnostic to identify
a broader range of patients with stage III or metastatic non-small
cell lung cancer (NSCLC) for first-line treatment with KEYTRUDA, a
targeted anti-PD-1 therapy manufactured by Merck & Co. (known
as MSD outside the United States and Canada).
The FDA previously approved the assay to identify metastatic
NSCLC patients whose tumors express PD-L1 Tumor Proportion Score
(TPS) ≥ 50% for first-line treatment with KEYTRUDA. Now, patients
with stage III NSCLC who are not candidates for surgical resection
or definitive chemoradiation, or metastatic NSCLC, and whose tumors
express PD-L1 TPS ≥ 1% are eligible for first-line treatment. This
expanded indication enables pathologists to identify a larger
population of previously untreated patients who are now eligible
for treatment with KEYTRUDA.
“Anti-PD-1 therapies are a promising treatment class for many
cancer types, and PD-L1 testing provides key information to
physicians managing stage III or metastatic NSCLC patients,” said
Sam Raha, president of Agilent’s Diagnostics and Genomics Group.
“The updated FDA approval of PD-L1 IHC 22C3 pharmDx broadens the
scope of patients that can be identified for first-line treatment
with KEYTRUDA and offers new hope to the many patients diagnosed
with stage III or metastatic NSCLC. By expanding the use of PD-L1
IHC 22C3 pharmDx, Agilent strives to continue our legacy of
pioneering companion diagnostics to support the launch of landmark
therapies.”
Lung cancer is the leading cause of cancer-related mortality in
the United States, with an estimated incidence of 154,000 deaths in
2018 alone.1 Among these cases, NSCLC accounts for nearly 85% of
all diagnoses, and carries a 5-year survival rate of 15%.2 PD-L1 is
a critical biomarker for response to anti-PD-1 therapy, and
pathology labs play an important role in identifying appropriate
patients for these treatments.
Agilent’s PD-L1 IHC 22C3 pharmDx is the first and only companion
diagnostic that has been clinically validated and approved to
identify NSCLC patients eligible for KEYTRUDA.
KEYTRUDA is a humanized monoclonal antibody that increases 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. KEYTRUDA and other
targeted immunotherapies are revolutionizing cancer treatment, and
their therapeutic value is being demonstrated across a growing list
of cancer types.
Agilent is a worldwide leader in partnering with pharmaceutical
companies to develop immunohistochemical-based diagnostics for
cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in
partnership with Merck & Co. PD-L1 IHC 22C3 pharmDx also helps
physicians identify cervical cancer, gastric or GEJ adenocarcinoma,
and urothelial carcinoma patients for treatment with KEYTRUDA.
PD-L1 expression in NSCLC tissues is interpreted using Tumor
Proportion Score (TPS). PD-L1 expression in urothelial carcinoma,
cervical cancer, and gastric or GEJ adenocarcinoma tissues is
interpreted using Combined Positive Score (CPS).
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
customers' most challenging questions. The company generated
revenues of $4.91 billion in fiscal 2018 and employs 15,300 people
worldwide. Information about Agilent is available at
www.agilent.com. To receive the latest Agilent news, subscribe to
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Facebook.
References:
1. Noone AM, Howlader N, Krapcho M, et al. SEER Cancer
Statistics Review, 1975-2015. National Cancer Institute.
https://seer.cancer.gov/csr/1975_2015/. November 2017 SEER data
submission. Published April 2018. Accessed September 21, 2018.
2. Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA.
Non-small cell lung cancer: Epidemiology, risk factors, treatment,
and survivorship. Mayo Clin Proc. 2008;83(5):584-594.
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Victoria Wadsworth-HansenAgilent Technologies+1 408 553 2005+45
2933 6980victoria.wadsworth-hansen@agilent.com
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