Telix Pharmaceuticals (ASX:TLX) has taken another step in expanding its neuro-oncology portfolio, announcing the submission of a European marketing authorisation application for its brain cancer imaging candidate TLX101-Px.
The company said the filing represents an important milestone in its strategy to integrate targeted diagnostic imaging with therapeutic radiopharmaceuticals across the cancer treatment pathway.
The Melbourne-based biotechnology company said the submission covers major European markets and forms part of a coordinated regulatory approach, with European and U.S. dossiers being prepared in parallel. Telix indicated that a U.S. New Drug Application is expected to follow as the program advances globally.
TLX101-Px is designed as a PET imaging agent for glioma, the most common type of primary brain tumour. Although similar imaging approaches are already used in Europe under limited hospital-based production, there is currently no widely available commercial product that provides consistent quality and access. Telix believes this gap highlights both a clinical need and an opportunity to improve patient care by expanding the availability of advanced imaging.
The company said it is seeking a broad clinical label aligned with current practice guidelines. If approved, the imaging agent could help clinicians distinguish tumour progression or recurrence from treatment-related effects, an area where conventional MRI scans can often provide inconclusive results and delay treatment decisions.
Across Europe, around 67,500 brain and central nervous system tumours are diagnosed each year, with gliomas accounting for a significant share of malignant cases. Improving diagnostic clarity is widely viewed as essential to treatment planning, particularly given the aggressive nature of many brain tumours and the need for rapid clinical decision-making.
TLX101-Px also has a strategic role beyond diagnosis, as it is being developed as a companion diagnostic and response-assessment tool for Telix’s investigational glioblastoma therapy TLX101-Tx. That therapy is currently being evaluated in a Phase 3 clinical study in Europe, reflecting Telix’s broader precision-medicine strategy of pairing imaging and treatment within the same molecular targeting framework.
If authorised, the product would be marketed in Europe under the proposed brand name Pixlumi, although final naming and launch timing remain subject to regulatory approval.