First Patient Dosed in Special Access Scheme in Australia for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent

Melbourne (Australia) | 26 April 2024

Telix today announces that the first patient has been dosed in a Special Access Scheme (SAS) in Australia for TLX250-CDx (⁸⁹Zr-DFO-girentuximab, Zircaix®¹) positron emission tomography (PET) imaging in clear cell renal cell carcinoma (ccRCC).

The patient was treated at the Olivia Newton-John Cancer Wellness Centre at Austin Health in Melbourne, a top recruiting site in Telix’s successful global Phase III ZIRCON study of TLX250-CDx (ClinicalTrials.gov Identifier: NCT03849118), which met all co-primary and secondary endpoints².

In Australia, in exceptional circumstances and where there is unmet medical need, physicians can apply to access unapproved products for individual patients through a SAS.

Associate Professor Andrew Weickhardt, Medical Oncologist at the Olivia Newton-John Cancer Wellness Centre, commented, “It is great to now have access to this novel imaging modality, which, based on performance in clinical trials, we hope will be able to answer questions relevant to our patients. This investigational imaging tracer has demonstrated the potential to provide a clear diagnosis and treatment plan for patients with ccRCC, without the need for invasive biopsy, the standard of care, which is not always conclusive or possible.”

Telix has commenced the regulatory filing for TLX250-CDx (Zircaix®¹) with the U.S. Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission³ and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions.

Physicians in Australia who may have eligible patients can email [email protected] for further information about TLX250-CDx named patient access. For more information about ongoing clinical trials of TLX250-CDx, please visit https://telixpharma.com/our-portfolio/clinical-trials/

Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

TLX250-CDx has not received a marketing authorisation in any jurisdiction. Zircaix® brand name is subject to final regulatory approval.