Telix Pharmaceuticals (ASX: TLX) has granted Fast Track designation by the US FDA for the company’s investigational glioma imaging product.
The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
This designation enables expedited review and closer consultation with the FDA during the review process.
Amino acid PET is currently included in US and European guidelines for the imaging of gliomas, however there is no FDA-approved targeted PET agent for brain cancer imaging in the U.S. Telix’s goal is to make this product commercially available in the US, significantly increasing patient access to this important imaging agent.
Telix has an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF). UCSF is one of the leading academic centres conducting clinical research into the use of FET PET in a variety of neurological malignancies. This academic-industrial collaboration supporting joint development and commercialisation will enable Telix to offer TLX101- CDx access as a commercial product in the U.S., subject to regulatory approval.
“There is critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting, and we are excited to leverage the clinical experience at UCSF to help make this investigational agent more widely available,” Thomas Hope, MD, Professor of Radiology at UCSF, said.
“18F-FET has the potential to help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where MRI5 – the standard of care – can often be inconclusive.”
TLX101-CDx (PixclaraTM2) is a PET imaging agent, which has been previously granted orphan drug designation (ODD) in the US as an imaging agent for the management of glioma.
Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue.
