The designation is specifically for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
TLX101-CDx is a PET imaging agent that targets membrane transport proteins LAT1 and LAT2, which could potentially be used as a companion diagnostic agent to TLX101, Telix’s investigational glioblastoma therapy.
The designation will facilitate a more expedited review process and closer consultation with the FDA.
The company is also in the final stages of preparing its New Drug Application (NDA) for TLX101-CDx for both adult and paediatric patients.
Currently, amino acid PET is included in the US and European guidelines for glioma imaging, but there is no FDA-approved targeted PET agent for brain cancer imaging in the US.
Telix has entered into an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF), an academic centre for clinical research into FET PET in neurological malignancies.
This partnership will support the joint development and commercialisation of TLX101-CDx in the US market, pending regulatory approval.
For commercial manufacturing and pharmacy distribution in the US market, Telix has partnered with PharmaLogic.
PharmaLogic will supply finished unit doses of TLX101-CDx, ensuring the product’s availability upon approval.
Telix group chief commercial officer Richard Valeix said: “These milestones represent significant progress as we bring this investigational product closer to market in the US and commercial launch.”
Recently, Telix acquired Canadian radioisotope production technology company ARTMS.