Telix Files Marketing Application In Europe For TLX101-Px Brain Cancer Imaging Agent As Company Aligns Submission With Upcoming U.S. FDA Package

Telix announced that it has submitted a Marketing Authorization Application (MAA) in Europe for TLX101-Px, an imaging candidate designed for detecting glioma, a type of brain cancer. This candidate uses 18F-FET, a radioactive tracer that supports more accurate imaging of brain tumors. The Company has been preparing both the European and U.S. regulatory applications in parallel. The European submission was completed earlier to meet an agreed deadline, while key elements were aligned with the material being prepared for the U.S. Food and Drug Administration. The application covers major markets across the European region, with the goal of making advanced glioma imaging more widely accessible and ensuring its use reflects modern clinical practice guidelines. Telix plans to submit the U.S. New Drug Application after the European review is underway.

Currently in Europe, positron emission tomography (PET) imaging for glioma using 18F-FET is limited because it is typically produced only at select hospital-based facilities under physician supervision, and no commercially available product exists to provide consistent quality and broad access. This creates an urgent gap in care for patients who rely on accurate imaging to differentiate between tumor progression and changes caused by treatment. Telix aims to address this gap by introducing TLX101-Px as a standardized, commercially accessible radiopharmaceutical. 

The product is intended for both adults and children and may support additional future uses beyond its initial indication. TLX101-Px is also being developed as a tool to help identify appropriate patients and assess treatment response for Telix’s glioblastoma therapy candidate, TLX101-Tx, which has orphan drug designation in both Europe and the United States. The therapy is currently advancing into the Phase 3 IPAX-BrIGHT trial for recurrent glioblastoma and will be launched across multiple European countries.

Philipp Lohmann, Group Leader of Digital Translational Neuroimaging at Forschungszentrum Jülich, explained that FET-PET imaging already plays an important role in the clinical evaluation of gliomas in Europe. He noted that it is especially valuable after treatment, when conventional MRI often struggles to distinguish true tumor progression from treatment-related effects. According to him, broader availability of TLX101-Px could give clinicians a more reliable tool to guide their decisions and manage patient care more effectively.

Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, stated that Europe represents a significant opportunity to expand access to highly targeted radiopharmaceuticals for diagnosing and treating brain cancer. He emphasized that submitting the MAA marks an important step in the Company’s strategy to build a complete imaging-and-therapy ecosystem for glioma. Richardson added that the ability to draw on parts of the FDA submission helped accelerate the European filing, which was delivered on an agreed timeline. A U.S. submission is expected to follow, supporting Telix’s broader goal of establishing widely accessible glioma imaging alongside its therapeutic programs.