Agilent has announced that it has received FDA approval for the MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to identify patients with synovial sarcoma who may qualify for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), an engineered TCR T-Cell therapy targeting MAGE-A4. MAGE-A4 (melanoma-associated antigen A4) is a cancer-testis antigen found in various cancers, including synovial sarcoma. The MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay designed to detect MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. Detection of MAGE-A4 in synovial sarcoma is a biomarker for eligibility for TECELRA® treatment. This marks MAGE-A4 IHC 1F9 pharmDx as the first in vitro diagnostic (IVD) for MAGE-A4 available on the market.
“MAGE-A4 is a key player in cancer research and shows great potential as a therapeutic target. The FDA’s approval of Agilent’s MAGE-A4 IHC 1F9 pharmDx will enhance treatment options for individuals with synovial sarcoma,” said Lou Welebob, Vice President and General Manager of Agilent’s Pathology Division. “This approval underscores Agilent’s leading role in developing companion diagnostics for innovative cancer therapies.”
TECELRA® is a prescription medication approved for advanced MAGE-A4 positive synovial sarcoma in adults with specific HLA types who have undergone prior chemotherapy. It is the first FDA-approved engineered TCR T-Cell therapy for solid tumors.
