Australian pharmaceutical company Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced on Thursday that the marketing authorisation 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 says that it is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflecting current clinical practice guidelines.

Assuming a positive outcome from the application at Day 210, national marketing authorisations are expected to follow shortly after.

The company says that 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 United States. 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 relevant European markets, the proposed brand name for TLX101-Px is Pixlumi. Brand name and commercial launch are subject to final regulatory approval.