Melbourne (Australia) | 12 April 2024

Telix today welcomes updated guidelines from the European Association of Urology (EAU) that for the first time include TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab) as an emerging technology for the management of renal cell carcinoma (RCC). 

Latest guidelines were issued at the 39th Annual EAU Congress (EAU24) that concluded in Paris this week2 and are a key resource for establishing clinical practice standards for urologic oncology in Europe. 

The EAU RCC Guidelines Panel recognises a growing body of evidence with regard to PET-CT3 with 89Zr-DFO-girentuximab, a monoclonal antibody that targets carbonic anhydrase IX (CAIX). This is based on results from Telix’s global Phase III ZIRCON trial in clear cell renal cell carcinoma (ccRCC),4 which met all primary and secondary endpoints and demonstrated a 93% positive-predictive value (PPV) for ccRCC.5 

David N. Cade, MD, Group Chief Medical Officer at Telix, stated, “The recognition of TLX250-CDx PET imaging for the first time in EAU guidelines as an emerging technology is an important development for Telix. This will help to raise awareness amongst the urology community of the potential of this investigational agent to reliably detect clear cell renal cell carcinoma, the most common and aggressive type of kidney cancer, and provide an accurate, non-invasive method for diagnosing ccRCC.” 

For more on TLX250-CDx and Telix’s theranostic kidney cancer program, click here. 

TLX250-CDx has not received a marketing authorisation in any jurisdiction. 

  1. Brand name subject to final regulatory approval.  ↩︎
  2. EAU Guidelines on Renal Cell Carcinoma (April 2024), available at: https://uroweb.org/guidelines/renal-cell-carcinoma.   ↩︎
  3. Positron emission tomography/computed tomography.  ↩︎
  4. ClinicalTrials.gov ID: NCT03849118.  ↩︎
  5. Telix ASX disclosures 7 November 2022.  ↩︎