Melbourne (Australia) | 25 March 2024
Telix today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (89Zr-DFO-girentuximab, Zircaix®1). TLX250-CDx is the Company’s investigational non-invasive carbonic anhydrase IX (CAIX) targeting positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.
The first patient was dosed at IRCCS Ospedale San Raffaele in Milan, Italy. Through this program (‘accesso allargato’), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC.
This follows the completion of Telix’s successful global Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov Identifier: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints.2
Arturo Chiti, Professor in Diagnostic Imaging and Radiotherapy at IRCCS Ospedale San Raffaele commented, “Continued access in Europe to TLX250-CDx is vitally important to enable early detection of ccRCC, which can often be challenging and reliant on invasive biopsy and nephrectomy (kidney removal). In TLX250-CDx, I am extremely pleased to be able to offer a non-invasive ‘Molecular Biopsy™’ to address unmet need in my patients in Italy.”
Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region continued, “We are pleased to support unmet patient need by adding a second European country to Telix’s global expanded access program for TLX250-CDx. Through the ZIRCON study, this investigational agent has demonstrated high sensitivity and specificity in the detection of ccRCC with potential to change standard of care in the diagnosis and management of this most aggressive form of kidney cancer.”
In Italy, the use of a medicinal product in an individual patient prior to marketing authorisation and outside the context of a clinical trial is permitted in exceptional circumstances and regulated by the Ministry of Health.
Italy becomes the third active country in Telix’s global expanded access program, where first patients were dosed in the Netherlands3 and the United States (U.S.)4 in December 2023. 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 submission5 and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions.
Physicians in Europe who may have eligible patients can email eap-emea@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.