Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy
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
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.
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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
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- 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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Naomi Goumillout
Agilent Technologies
+1.978.314.1862
naomi.goumillout@agilent.com
Source: Agilent Technologies Inc.