New Imaging Agent to Drive Step-Change for Brain Cancer Imaging

They represent the most prevalent type of central nervous system (CNS) neoplasm originating from glial cells, accounting for around 30% of all brain and CNS tumors and approximately 80% of malignant brain tumors. There is a significant unmet need to enhance the diagnosis and management of gliomas, particularly after treatment. Traditional MRI imaging techniques have various limitations, such as a lack of biological specificity, reliance on the disruption of the blood-brain barrier, and an intrinsic inability to distinguish between tumor progression and treatment-related changes. These issues can lead to inconclusive results, delaying critical treatment decisions. With low survival rates and the necessity for prompt actions, precision imaging becomes essential. Now, a new PET imaging agent for gliomas has the potential to meet this need, providing patients with clearer diagnoses and aiding treatment decision-making.

Telix Pharmaceuticals (Melbourne, Australia) has developed Pixclara (18F-floretyrosine or 18F-FET), a PET agent designed to differentiate between progressive or recurrent gliomas and treatment-related changes in both adult and pediatric patients. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara), an imaging agent for gliomas. This application has been given priority review status, with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2025, facilitating a potential U.S. commercial launch in 2025.

While FET PET is already part of international clinical practice guidelines for glioma imaging, there is currently no FDA-approved targeted amino acid PET agent available for adult and pediatric brain cancer imaging in the U.S. Given its potential to fulfill a significant medical need, Pixclara has been designated as an orphan drug and granted fast track designation by the FDA. Telix is also exploring the possibility of using Pixclara as a companion diagnostic agent for TLX101-Tx, an investigational neuro-oncology drug in development that targets the same amino acid transporter mechanism with therapeutic radiation.

“Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S., and bring it into line with a more advanced standard of care currently used in other markets,” said Kevin Richardson, Chief Executive Officer, Telix Precision Medicine. “There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.”

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