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FDA Permits Compassionate Use of Telix's Glioma PET Imaging Agent

NextEdge Admin

01 Aug 2024

1 min 43 sec

Telix Pharmaceuticals has launched an expanded access program in the US to increase the availability of its PET imaging agent TLX101-CDx (18F-floretyrosine or 18F-FET) for patients with advanced glioma. This initiative is part of the company's preparation to file a new drug application for TLX101-CDx in the third quarter, under the US Food and Drug Administration's compassionate use program.

This expanded access allows patients with advanced or recurrent glioma to use TLX101-CDx outside of clinical trials. Telix has utilized TLX101-CDx in clinical trials to identify brain cancer patients suitable for its radiopharmaceutical TLX101 (131I-IPA). Both the imaging agent and the therapeutic target two membrane transport proteins: large amino acid transporter 1 (LAT1) and large amino acid transporter 2 (LAT2).

The program aims to enhance access to TLX101-CDx, which Telix believes could improve diagnosis and imaging-based treatment decisions compared to MRI technology. While guidelines in the US and Europe recommend amino acid PET imaging for glioma patients, the FDA has yet to approve a targeted amino acid PET imaging agent for commercial use.