CORRECTING & REPLACING Agilent Technologies Receives Expanded FDA Approval for the Use of Dako PD-L1 IHC 22C3 pharmDx Compani...
September 22 2017 - 6:01PM
Business Wire
Patients with gastric or GEJ adenocarcinoma whose tumors
express PD-L1 can now be identified for potential treatment with
KEYTRUDA® (pembrolizumab) using PD-L1 IHC 22C3
pharmDx
Third paragraph of release should read: The expanded approvals
for PD-L1 IHC 22C3 pharmDx and KEYTRUDA means that these patients
now have the possibility of receiving a targeted anti-PD-1
immunotherapy (instead of The expanded approvals for PD-L1 IHC 22C3
pharmDx and KEYTRUDA means that these patients now have the
possibility of receiving a targeted anti-PD-L1 immunotherapy).
The corrected release reads:
AGILENT TECHNOLOGIES RECEIVES EXPANDED FDA APPROVAL FOR THE
USE OF DAKO PD-L1 IHC 22C3 PHARMDX COMPANION DIAGNOSTIC IN GASTRIC
OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER
Patients with gastric or GEJ adenocarcinoma whose tumors
express PD-L1 can now be identified for potential treatment with
KEYTRUDA® (pembrolizumab) using PD-L1 IHC 22C3
pharmDx
Agilent Technologies Inc. (NYSE: A) today announced its Dako
PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by U.S.
Food and Drug Administration (FDA), for use as an aid in
identifying gastric or GEJ adenocarcinoma patients for treatment
with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy manufactured
by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD
outside the United States and Canada).
The FDA also announced on September 22 that KEYTRUDA is now
approved for the treatment of patients with recurrent locally
advanced or metastatic gastric or gastroesophageal junction (GEJ)
adenocarcinoma. These tumors express PD-L1 [Combined Positive Score
(CPS) ≥1] as determined by an FDA-approved test, with disease
progression on or after two or more prior lines of therapy,
including fluoropyrimidine- and platinum-containing chemotherapy
and if appropriate, HER2/neu-targeted therapy.
The expanded approvals for PD-L1 IHC 22C3 pharmDx and KEYTRUDA
means that these patients now have the possibility of receiving a
targeted anti-PD-1 immunotherapy.
Gastric cancer is the fifth most common malignancy worldwide and
the third most common cause of cancer death. The prognosis for
patients diagnosed with advanced stage IV gastric cancer is poor,
with only a 4% five-year observed survival rate*. Previously,
gastric or GEJ adenocarcinoma patients had few therapeutic options,
and those available included highly toxic chemotherapy.
First approved by U.S. FDA in October 2015, for determining
PD-L1 expression levels in patients with NSCLC, PD-L1 IHC 22C3,
pharmDx is the first FDA-approved assay for the identification of
PD-L1 expression in patients with gastric or GEJ adenocarcinoma for
treatment with the anti-PD-1 therapy KEYTRUDA.
“We are pleased that the U.S. FDA approved the expansion of use
for PD-L1 IHC 22C3 pharmDx assay, as it gives patients with gastric
or GEJ cancer the possibility of having their tumor sample tested
for PD-L1 expression, and determining eligibility for treatment
with KEYTRUDA.” said Jacob Thaysen, president of Agilent's
Diagnostics and Genomics Group.
PD-L1 IHC 22C3 pharmDx was used to assess PD-L1 expression in
patients treated with KEYTRUDA in the KEYNOTE-059 trial.
KEYNOTE-059 is a registrational, phase 2, global, multicenter,
non-randomized, open-label multicohort trial investigating the use
of KEYTRUDA in patients with advanced gastric or GEJ
adenocarcinoma.
PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck
& Co., Inc., Kenilworth, N.J., USA, manufacturer 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.
Agilent is a worldwide leader in partnering with pharmaceutical
companies to develop immunohistochemical-based diagnostics for
cancer therapy.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A), is a global leader in
analytical laboratory technologies. With more than 50 years of
insight and innovation, our instruments, software, services,
solutions, and people provide trusted answers to our customers'
most challenging questions. The company generated revenues of $4.20
billion in fiscal 2016 and employs about 13,000 people worldwide.
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 here, and information about
Agilent's Dako products is available here.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA
*http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
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Agilent TechnologiesVictoria Wadsworth-Hansen, +1 408-553-2005
or +45.2933.6980victoria.wadsworth-hansen@agilent.com
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