Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(2-[¹⁸F]fluoroethyl)-L-tyrosine, ¹⁸F-FET), its glioma (brain cancer) imaging candidate.

Telix has been preparing the European and U.S. regulatory packages for TLX101-Px concurrently, bringing forward the European submission to meet an agreed filing date while aligning with aspects of the U.S. Food and Drug Administration (FDA) package to support the additional application. The submission covers major European markets¹. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines². Submission of the U.S. New Drug Application (NDA) will follow.

In Europe, positron emission tomography (PET) imaging of glioma with ¹⁸F-FET (FET-PET) is currently performed under physician-supervised use through hospital-based production at a limited number of sites. However, there is currently no generally available commercial product in Europe that ensures consistent quality and access for glioma imaging, an acute and immediate need³. Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx (iodofalan ¹³¹I), which has been granted orphan drug designation in Europe and the U.S. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma, launching in multiple European countries⁴.

Philipp Lohmann, Group Leader Digital Translational Neuroimaging at Forschungszentrum Jülich research center in Germany, commented, “FET-PET imaging is already used in clinical practice in Europe for the evaluation of gliomas, and plays a critical role in treatment decision making. This applies particularly in the post-therapy setting, where conventional MRI⁵ alone can be limited in its ability to distinguish tumor progression from treatment-related changes. Having widespread access to TLX101-Px has potential to provide clinicians with greater biological insight, supporting more confident and timely management of patients with brain tumors.”

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, added, “We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix. The strategic value of this submission is particularly relevant to establishing widespread glioma imaging as part of our corresponding therapeutic development program. We have been able to utilize aspects of our FDA package to expedite the European filing, which has been submitted in accordance with a pre-defined date agreed with the regulator, with the U.S. resubmission to follow.”