Telix Pharmaceuticals announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara®^[1], ¹⁸F-floretyrosine or ¹⁸F-FET), an investigational PET agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Given the potential to address significant unmet medical need, Pixclara®¹ has been granted Orphan Drug and Fast Track designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process. FET PET (Pixclara®¹) is already included in international clinical practice guidelines for the imaging of gliomas^[5], however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

There is a critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. With low survival rates and the need to make rapid decisions, precision imaging is paramount. Subject to regulatory approval, Pixclara®¹ has the potential to address this need, enabling patients to receive greater clarity in their diagnosis and treatment decision making. Pixclara®¹ is also being developed as the "companion" theranostic imaging agent for TLX101, Telix's investigational neuro-oncology drug candidate, which targets the same amino acid transporter mechanism with therapeutic targeted radiation.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, stated, "Gliomas are the most common primary brain tumours of the central nervous system. Conventional imaging with MRI^[6] often yields inconclusive results in characterising recurrent disease and therefore delays time-sensitive decision making⁴. 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^[7]. Telix's filing of this NDA for Pixclara®¹ is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the U.S., and taking us one step closer to commercial availability in 2025, subject to FDA approval."