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
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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240802261119/en/
+1.978.314.1862
naomi.goumillout@agilent.com
Source: