Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy
2024年8月2日 - 9:00PM
ビジネスワイヤ(英語)
MAGE-A4 IHC 1F9 pharmDx is indicated as an aid in identifying
patients with synovial sarcoma for whom TECELRA®, a
MAGE-A4-directed engineered T-Cell Receptor (TCR) therapy is being
considered
Agilent Technologies Inc., (NYSE: A) today announced that it has
received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx
(SK032) as a diagnostic tool to aid in identifying patients with
synovial sarcoma who may be eligible for treatment with TECELRA®
(afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a
MAGE-A4-directed engineered TCR T-Cell therapy.
MAGE-A4 (melanoma-associated antigen A4) is a cancer-testis
antigen overexpressed in various cancers, including synovial
sarcoma. MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC)
assay used to detect MAGE-A4 expression in formalin-fixed
paraffin-embedded (FFPE) synovial sarcoma tissue. MAGE-A4
positivity in synovial sarcoma is a biomarker of eligibility for
treatment with TECELRA®. MAGE-A4 IHC 1F9 pharmDx is the first IVD
for MAGE-A4 available on the market.
“MAGE-A4 plays a significant role in cancer research and holds
promise as a therapeutic target. The FDA’s approval of Agilent’s
MAGE-A4 IHC 1F9 pharmDx will expand treatment options for
individuals diagnosed with synovial sarcoma,” stated Lou Welebob,
vice president and general manager of Agilent’s Pathology Division.
“This endorsement amplifies Agilent’s pioneering role in shaping
companion diagnostics for groundbreaking cancer therapies.”
TECELRA, is a prescription medicine approved for advanced
MAGE-A4 positive synovial sarcoma in adults with certain HLA types
who have received prior chemotherapy. TECELRA is the first
FDA-approved engineered TCR T-Cell therapy for a solid tumor
cancer.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in
analytical and clinical laboratory technologies, delivering
insights and innovation that help our customers bring great science
to life. Agilent’s full range of solutions includes instruments,
software, services, and expertise that provide trusted answers to
our customers' most challenging questions. The company generated
revenue of $6.83 billion in fiscal 2023 and employs approximately
18,000 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 and Facebook.
References:
- Synovial Sarcoma - NCI (cancer.gov) |
https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma
- Collini, A. F. M. a. P., MD. (n.d.). Synovial Cell Sarcoma:
Diagnosis, Treatment, Support & Research. Liddy Shriver.
Sarcoma Initiative.
https://sarcomahelp.org/synovial-sarcoma.html
- Aytekin MN, Öztürk R, Amer K, Yapar A. Epidemiology, incidence,
and survival of synovial sarcoma subtypes: SEER database analysis.
Journal of Orthopaedic Surgery. 2020;28(2).
doi:10.1177/2309499020936009
- Landuzzi, L.; Manara, M.C.; Pazzaglia, L.; Lollini, P.-L.;
Scotlandi, K. Innovative Breakthroughs for the Treatment of
Advanced and Metastatic Synovial Sarcoma. Cancers 2023, 15, 3887.
https://doi.org/10.3390/cancers15153887
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version on businesswire.com: https://www.businesswire.com/news/home/20240802261119/en/
Naomi Goumillout Agilent Technologies +1.978.314.1862
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
過去 株価チャート
から 8 2024 まで 9 2024
Agilent Technologies (NYSE:A)
過去 株価チャート
から 9 2023 まで 9 2024