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FDA Allowing Compassionate Use Access to Telix's Glioma PET Imaging Agent

This story has been updated to clarify that Telix is not currently using TLX101-CDx to select glioma patients for its therapeutic clinical trial, but may do so in the future.

NEW YORK – Telix Pharmaceuticals said this week that it has launched an expanded access program in the US aimed at increasing availability of its PET imaging agent TLX101-CDx (18F-floretyrosine or 18F-FET) for patients with advanced glioma. 

The US Food and Drug Administration is allowing Telix to provide the imaging agent under its compassionate use program as the Melbourne, Australia-based firm gears up to file a new drug application for TLX101-CDx in the third quarter. Through the program, patients with advanced or recurrent glioma will be able to access TLX101-CDx outside of a clinical trial. 

Telix has been using TLX101-CDx in clinical trials to monitor brain cancer patients' responses to its radiopharmaceutical TLX101 (131I-IPA). In the future, Telix may also use TLX101-CDx to determine patient eligibility for the therapeutic. Both the imaging agent and therapeutic are designed to home in on two membrane transport proteins: large amino acid transporter 1 (LAT1) and large amino acid transporter 2 (LAT2). 

The expanded access program is focused specifically on broadening access to TLX101-CDx, which Telix believes can potentially improve diagnosis and imaging-based treatment decisions compared to MRI technology. Guidelines bodies in the US and Europe recommend glioma patients receive amino acid PET imaging, but the FDA has never approved a targeted amino acid PET imaging agent for commercial use.