Telix Pharmaceuticals Limited announced that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (89Zr-DFO-girentuximab, Zircaix?. 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. 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 Netherlands and the United States (U.S.) in December 2023. Telix has commenced the regulatory filing for TLX250-CD x (Zircaix??) with the U.S. Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions.