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

SANTA CLARA, Calif.--(BUSINESS WIRE)--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:

1. Synovial Sarcoma - NCI (cancer.gov) | https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma
2. 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
3. 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
4. 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