Expanded Access Program Opens for Telix’s Investigational Glioma Imaging Agent

Telix announced the opening of an expanded access program (EAP) in the US for TLX101-CDx (Pixclara, F-floretyrosine or 18F-FET) an investigational PET agent for imaging progressive or recurrent glioma, following US FDA agreement to proceed.

Amino acid PET is included in US and European clinical practice guidelines for the imaging of gliomas, however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the US. Telixʼs goal is to make this product commercially available in the US, significantly increasing patient access to this important imaging agent for both adult and pediatric patients. The company expects to file its New Drug Application (NDA) for TLX101-CDx with the FDA during Q3 2024.

Patrick Wen, MD, Professor, Neurology, Harvard Medical School and Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, said, “Amino acid PET imaging of the brain is increasingly used to supplement conventional imaging by MRI3, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease. After treatment, MRI has several limitations, including the lack of biological specificity, dependency on blood-brain barrier disruption, and an inability to differentiate between tumor progression or recurrence from treatment-related changes. TLX101-CDx (FET-PET) shows potential to provide a more rapid and conclusive diagnosis, inform David N. Cade, MD, Telix Chief Medical Officer, added, “As we finalize the submission of our NDA for TLX101-CDx, the opening of this expanded access program will enable us to provide continued access to this investigational agent, where there is significant unmet medical need in the U.S. Glioma is the most common and aggressive form of primary brain cancer and we believe TLX101-CDx has the potential to make an important difference for U.S. glioma patients who deserve greater reliability in their diagnosis and treatment decision making.”

Under its EAPs – sometimes also called ‘compassionate useʼ – the FDA works with companies to allow access to investigational products, outside of a clinical trial, to patients with serious or life-threatening illnesses, for whom there are no comparable or satisfactory alternate options.