Telix Pharmaceuticals Limited (ASX: TLX), an Australia-based biopharmaceutical company, announced on Wednesday that it has submitted a New Drug Application (NDA) to the United States (US) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara, 18F-floretyrosine or 18F-FET), an investigational positron emission tomography (PET) agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and paediatric patients.

The product has received Orphan Drug and Fast Track designation from the FDA to facilitate accelerated review and closer consultation with the agency during the review process. It is already included in international clinical practice guidelines for the imaging of gliomas, but there is presently no FDA-approved targeted amino acid PET agent for adult and paediatric brain cancer imaging commercially available in the United States.

Kevin Richardson, Telix Precision Medicine chief executive officer, said: "Gliomas are the most common primary brain tumours of the central nervous system. Conventional imaging with MRI often yields inconclusive results in characterising recurrent disease and therefore delays time-sensitive decision making. Limitations of conventional imaging techniques include the lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes. Telix's filing of this NDA for Pixclara is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the US, and taking us one step closer to commercial availability in 2025, subject to FDA approval."