TLX101-CDx (Pixclara) Granted FDA Fast Track Designation

• FDA Fast Track designation granted for TLX101-CDx for glioma (brain cancer) imaging
  
• Collaboration agreement announced for joint development and commercialisation with UCSF
• PharmaLogic announced as commercial manufacturing and pharmacy distribution partner
  

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation¹ for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara², ¹⁸F-floretyrosine or ¹⁸F-FET).

The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients. This designation enables expedited review and closer consultation with the FDA during the review process.

Amino acid PET is currently included in U.S. and European guidelines for the imaging of gliomas³, however there is no FDA-approved targeted PET agent for brain cancer imaging 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.

Collaboration with the University of California, San Francisco

Telix has an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF). UCSF is one of the leading academic centres conducting clinical research into the use of FET PET⁴ in a variety of neurological malignancies. This academic-industrial collaboration supporting joint development and commercialisation will enable Telix to offer TLX101-CDx access as a commercial product in the U.S., subject to regulatory approval.

Thomas A. Hope, MD, Professor of Radiology at UCSF, said, “There is critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting, and we are excited to leverage the clinical experience at UCSF to help make this investigational agent more widely available. ¹⁸F-FET has the potential to help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where MRI⁵ – the standard of care – can often be inconclusive.”