Telix Pharmaceuticals Limited (ASX: TLX) has revealed a significant development in its investigational positron emission tomography (PET) imaging agent, TLX250-CDx, designed for the characterization of clear cell renal cell carcinoma (ccRCC). The company announced the initiation of a named patient (early access) program in the Netherlands, allowing physicians to seek individual access to TLX250-CDx for PET characterization of renal masses as ccRCC.
The first patient was successfully dosed at Radboud University Medical Centre in Nijmegen, Netherlands, marking a crucial milestone in the program. This initiative, known as ‘Leveren op Artsenverklaring,’ enables physicians to access TLX250-CDx on a named patient basis, offering a non-invasive option for the assessment of ccRCC.
The named patient program follows the successful completion of Telix’s global Phase III ZIRCON study (ClinicalTrials dentifier: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints. The ZIRCON study demonstrated TLX250-CDx to be highly sensitive and specific in the detection of ccRCC, addressing challenges associated with early-stage disease detection through invasive procedures.
Professor Dr. Peter Mulders from Radboud University Medical Centre, a Principal Investigator on Telix’s ZIRCON trial, emphasized the importance of continued access to this investigational imaging agent. He highlighted that the non-invasive nature of TLX250-CDx, often referred to as a ‘molecular biopsy,’ is particularly valuable in overcoming challenges related to early-stage ccRCC detection.
Frédéric Fantino, Telix Medical Director for the Europe, Middle East, and Africa (EMEA) region, expressed the significance of this step in supporting unmet patient needs and educating key opinion leaders on TLX250-CDx’s potential to revolutionize standard care in ccRCC diagnosis and management.
In the Netherlands, the use of TLX250-CDx in individual patients before marketing authorization and outside a clinical trial is permitted under exceptional circumstances. The treating physician initiates individual requests, which are evaluated by the Dutch Health Inspectorate (IGJ).
Telix is actively progressing towards a Biologics License Application (BLA) submission for TLX250-CDx with the United States Food and Drug Administration (FDA) and equivalent applications with regulatory agencies in key commercial jurisdictions.
Physicians in Europe with eligible patients can obtain further information about TLX250-CDx named patient access by emailing email@example.com.
For ongoing clinical trial information and Telix’s Policy on Offering Compassionate Use to Investigational Medicines, visit Telix’s official website.
Telix Pharmaceuticals Limited is a biopharmaceutical company headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. The company is focused on developing and commercializing diagnostic and therapeutic radiopharmaceuticals and associated medical devices, with a portfolio targeting significant unmet medical needs in oncology and rare diseases. Telix is publicly listed on the Australian Securities Exchange (ASX: TLX).