Full Press Release Details
Melbourne (Australia) | 11 December 2023
Telix today announces that the first patient has been dosed in a United States (U.S.) expanded access program (EAP, ClinicalTrials.gov ID: NCT06090331 ) for TLX250-CDx ( 89 Zr-DFO-girentuximab). TLX250-CDx is the Company’s first-in-class, non-invasive investigational positron emission tomography (PET) imaging agent in clear cell renal cell carcinoma (ccRCC).
The patient was dosed at ARA Diagnostic Imaging at Austin Radiological Association in Austin (TX, U.S.) following U.S. Food and Drug Administration (FDA) agreement to proceed.
FDA agreement for an EAP follows the completion of Telix’s successful global Phase III ZIRCON study ( Zi rconium i n R enal C ancer On cology, ClinicalTrials.gov ID: NCT03849118 ), which reported positive results in November 2022, meeting all co-primary and secondary endpoints. [1]
Dr John Leahy, molecular radiologist and nuclear medicine specialist at ARA Diagnostic Imaging and a Principal Investigator on the EAP stated, “With TLX250-CDx, for the first time, urologists and urologic oncologists may have a non-invasive way to determine the presence of ccRCC, the most common and aggressive form of kidney cancer. We are therefore extremely pleased to have been selected as the inaugural site for this national EAP, with patients in Austin and the surrounding area now able to benefit from greater confidence in their kidney cancer diagnosis and treatment planning.”
Mary Jessel, Senior Vice President of Global Medical Affairs at Telix added: “Ahead of regulatory approval, this EAP provides continued access to TLX250-CDx to address a clear unmet patient need. ZIRCON results demonstrate that TLX250-CDx has potential to become a new standard of care in the diagnosis and staging of ccRCC, where existing imaging can be inconclusive.”
Under its EAPs – sometimes called ‘compassionate use’ – the FDA works with companies to allow access to investigational products outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.
Telix is progressing towards a Biologics License Application (BLA) submission for TLX250-CDx with the FDA and other equivalent applications with regulatory agencies in key commercial jurisdictions.
U.S. patients, or physicians who may have eligible patients in the U.S., can e-mail eap-americas@telixpharma.com or complete the form here for further information about the TLX250-CDx EAP.
Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link .
For more information about ongoing clinical trials of TLX250-CDx, please visit https://telixpharma.com/our-portfolio/clinical-trials/
Read the full media release here
[1] Telix ASX disclosure 7 November 2022.