Telix (ASX:TLX) has submitted a New Drug Application (NDA) to the US FDA for TLX101-CDx (Pixclara, 18F-floretyrosine or 18F-FET), an investigational PET agent for the characterisation of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients.
The company said Pixclara had been granted orphan designation, reflecting its potential to address significant unmet medical needs.
Pixclara is already included in international clinical practice guidelines for the imaging of gliomas. However, no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging is currently commercially available in the US.
Pixclara is also being developed as the 'companion' theranostic imaging agent for TLX101, Telix's investigational neuro-oncology drug candidate. This drug candidate targets the same amino acid transporter mechanism with therapeutic targeted radiation.
The CEO of Telix Precision Medicine, Kevin Richardson, 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."
