Telix Pharmaceuticals (ASX:TLX) has been granted Fast Track designation by The United States Food and Drug Administration (FDA) for its brain cancer imaging software; TLX101-CDx (also known as Pixclara™).
This Fast Track designation is specifically for using TLX101-CDx with positron emission tomography (PET) to characterize progressive or recurrent glioma, a form of brain cancer.
Telix is currently 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.
While amino acid PET imaging is recommended in U.S. and European guidelines for glioma imaging, there is currently no FDA-approved targeted PET agent for brain cancer imaging in the U.S. Telix aims to change that by making TLX101-CDx commercially available in the U.S., which could significantly improve patient access to this important imaging tool – which the market currently lacks.
Furthermore, in order to develop TLX101-CDx, Telix has collaborated with the University of California, San Francisco, a leading academic center in neurological malignancy research. This collaboration supports joint development and commercialization efforts, paving the way for TLX101-CDx to become a commercial product in the U.S., whilst pending regulatory approval.
“F-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,” Thomas A. Hope, MD, Professor of Radiology at UCSF said.
Telix has partnered with PharmaLogic Holdings Corp (PharmaLogic) for manufacturing and distributing TLX101-CDx in the U.S. market – which is hoped to support its commercialisation efforts in the market.
TLX has been trading at $12.90.