Agilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer
November 13 2020 - 8:26PM
Business Wire
Announcement marks the seventh cancer type for which PD-L1 IHC
22C3 pharmDx has gained approval in the US
Agilent Technologies Inc. (NYSE: A) today announced it has
received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an
aid in identifying patients with triple-negative breast cancer
(TNBC) for treatment with KEYTRUDA® (pembrolizumab).
PD-L1 expression is a critical biomarker for response to
anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC
22C3 pharmDx strengthens the ability of pathologists to identify
patients who may be eligible for treatment with KEYTRUDA. KEYTRUDA,
in combination with chemotherapy, is approved for patients with
locally recurrent unresectable or metastatic TNBC whose tumors
express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by
an FDA-approved test.
PD-L1 IHC 22C3 pharmDx is the only companion diagnostic that is
FDA-approved to aid in the identification of TNBC patients for
treatment with KEYTRUDA in combination with chemotherapy. With TNBC
marking the seventh cancer type for which PD-L1 IHC 22C3 pharmDx
has gained FDA approval, Agilent is further solidifying its
position as a go-to partner for drug/diagnostic co-development.
PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small
cell lung cancer (NSCLC), gastric or gastroesophageal junction
(GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC),
cervical cancer, urothelial carcinoma, and head and neck squamous
cell carcinoma (HNSCC) patients for treatment with KEYTRUDA.
"Anti-PD-1 therapies, including KEYTRUDA, continue to offer new
treatment options for a growing population of cancer patients,"
said Nina Green, vice president and general manager of Companion
Diagnostics at Agilent. "With the expanded FDA approval of PD-L1
IHC 22C3 pharmDx in TNBC, physicians will be able to access
critical information to qualify even more patients who could
benefit from these treatments. This new approval reinforces
Agilent’s role as a worldwide leader in developing companion
diagnostics for targeted therapies."
Breast cancer is the most common type of cancer among women,
with 276,480 new cases estimated to be diagnosed in the United
States in 2020.1 Approximately 10% of breast cancer diagnoses are
TNBC.2
KEYTRUDA is a humanized monoclonal antibody that enhances the
ability of the immune system to detect and fight tumor cells.
KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes
that may affect both tumor cells and healthy cells. KEYTRUDA and
other targeted immunotherapies are changing cancer treatment, and
their therapeutic value is being realized across a growing list of
cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a
companion diagnostic for KEYTRUDA in partnership with Merck (known
as MSD outside the United States and Canada).
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets. In its 20th
year as an independent company delivering insight and innovation
toward improving the quality of life, Agilent instruments,
software, services, solutions, and people provide trusted answers
to customers' most challenging questions. The company generated
revenue of $5.16 billion in fiscal 2019 and employs 16,300 people
worldwide. Information about Agilent is available at
www.agilent.com. To receive the latest Agilent news, subscribe to
the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and
Facebook.
References:
1. Cancer of the Breast (Female) – Cancer Stat Facts.
https://seer.cancer.gov/statfacts/html/breast.html (accessed Oct
26, 2020)
2. Triple-negative breast cancer: is there a treatment on the
horizon? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5352107/
(accessed Nov 12, 2020)
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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