Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA[2] goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025[3].
Pixclara (18F-floretyrosine or 18F-FET) is a PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for the imaging of gliomas[4], 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. Given its potential to address significant unmet medical need, Pixclara has been designated as an orphan drug[5] and granted fast track designation[6] by the FDA.
There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumours of the central nervous system, particularly in the post-treatment setting. Conventional MRI[7] imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions[8].
1. Brand name subject to final regulatory approval.
[2] Prescription User Drug Fee Act.
[3] Subject to FDA marketing authorsation approval.
[4] Joint European Association of Nuclear Medicine//European Association of Neurooncology/Response Assessment in Neurooncology practice guidelines/Society for Nuclear Medicine and Molecular Imaging procedure standards for the clinical use of PET imaging in gliomas.
[5] Telix ASX disclosure 6 October 2020.
[6] Telix ASX disclosure 16 April 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
[7] Magnetic resonance imaging.
[8] Smith NJ et al. J Nucl Med. 2023.
