Original from: Agilent
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.
