Full Press Release Details
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 ( 89 Zr-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 endpoints 2 .
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 submission 3 and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions.
Physicians in Australia who may have eligible patients can email eap-apac@telixpharma.com 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.
• Brand name subject to final regulatory approval. ↩︎
• Telix ASX disclosure 7 November 2022. ↩︎
• Telix ASX disclosure 19 December 2023. ↩︎