Telix Pharmaceuticals Limited announced that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate, has been validated and accepted for review. The application, covering commercially significant European markets, has now moved into a 210-day active assessment phase. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines.
Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after. In Europe, there is currently no generally available commercial product for PET imaging of glioma with 18F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product. Through this MAA, 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. The Phase 3 IPAX-BrIGHT trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally and is launching in multiple European countries. In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year, with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting.
Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions. With low survival rates and the need to make rapid decisions, precision imaging is paramount.
Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making. TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine) is Telix's PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2).
This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix's LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix's IPAX-2 and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi".
Brand name and commercial launch are subject to final regulatory approval.
