Telix Pharmaceuticals Limited announced that the first patient has been dosed in a named patient (early access) program in the Netherlands for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. Through this named patient program in the Netherlands ('Leveren op Artsenverklaring'), physicians may seek individual access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC. The detection of ccRCC in the early stages of disease can often be challenging, and reliant on invasive biopsy and nephrectomy (kidney removal).

It is therefore extremely good news that TLX250-CDx, which offers a non-invasive option - or 'molecular biopsy' - is now available in the Netherlands on a named patient basis. In the Netherlands, 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. Individual requests must be initiated by the treating physician and are evaluated by the Dutch Health Inspectorate (IGJ).

Telix is progressing towards a Biologics License Application (BLA) submission for TLX250-CDx with the United States Food and Drug Administration (FDA) and other equivalent applications with regulatory agencies in key commercial jurisdictions. Physicians in Europe who may have eligible patients can email for further information about TLX250-CDx named patient access.