Telix Submits EU Approval Application for TLX101-Px Glioma PET Imaging
Telix has submitted a European marketing authorization application for TLX101-Px, its 18F-FET glioma PET imaging candidate, covering major European markets ahead of a planned U.S. NDA. The application aims to standardize brain cancer imaging access and dovetails with TLX101-Tx’s Phase 3 IPAX-BrIGHT glioblastoma therapy trial.
1. European MAA Submission
Telix has filed a marketing authorization application in Europe for TLX101-Px (18F-FET), targeting glioma imaging across major markets. This submission leverages components of its pending FDA package to meet a predefined filing date and paves the way for a subsequent U.S. NDA.
2. Addressing Unmet Clinical Needs
In current practice, glioma PET imaging with 18F-FET is performed under physician supervision at limited hospital sites, without a commercial product ensuring consistent quality. TLX101-Px seeks to broaden access to precision imaging that distinguishes tumor progression from treatment effects, supporting faster and more confident clinical decision making.
3. Strategic Link to Therapeutic Program
The TLX101-Px application aligns with development of TLX101-Tx (iodofalan 131I), Telix’s glioblastoma therapy candidate, which has orphan drug designation and is entering a Phase 3 IPAX-BrIGHT trial. Widespread imaging authorization is expected to facilitate patient selection, response assessment and future label expansion for both diagnostic and therapeutic radiopharmaceuticals.