Expanded Access Program Opens in the U.S. for TLX101-CDx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent

MELBOURNE, Australia, July 29, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara¹, ¹⁸F-floretyrosine or ¹⁸F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed.        

Amino acid PET is included in U.S. and European clinical practice guidelines for the imaging of gliomas², however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the U.S. Telix’s goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent for both adult and paediatric 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 tumour progression or recurrence from treatment-related changes. TLX101-CDx (FET-PET) shows potential to provide a more rapid and conclusive diagnosis, inform treatment decisions and deliver a new standard for the management of gliomas in the U.S.”

David N. Cade, MD, Telix Chief Medical Officer, added, “As we finalise 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.”