Telix Pharmaceuticals (ASX:TLX) has announced that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.
The application has been granted priority review and designated a PDUFA2 goal date of 26 April 2025, paving the way for a potential US commercial launch in 2025.
Pixclara is a PET agent for characterising progressive or recurrent glioma from treatment-related changes in adult and paediatric patients.
FET PET 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 commercially available in the US.
The FDA has designated Pixclara an orphan drug and granted fast-track designation by the FDA.
There is a critical unmet need to improve the diagnosis and management of gliomas, the central nervous system's most common primary brain tumours, particularly in the post-treatment setting.
Conventional MRI7 imaging techniques have several limitations, including 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.
With low survival rates and the need to make rapid decisions, precision imaging is paramount.
Telix said that subject to regulatory approval, Pixclara has the potential to address this need, enabling patients in the US to receive greater clarity in their diagnosis and treatment decision-making.
Telix is also reviewing the potential use of Pixclara as a companion diagnostic agent for TLX101-Tx, the investigational neuro-oncology drug currently in development, which targets the same amino acid transporter mechanism with therapeutic targeted radiation.
Kevin Richardson, CEO of Telix Precision Medicine, said, “Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the US and bring it into line with a more advanced standard of care currently used in other markets. There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.”
