Melbourne (Australia) | 30 December 2024
TLX250-CDx is an investigational PET[3] drug product for the non-invasive diagnosis and characterisation of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise.
The FDA is expected to advise the PDUFA[4] goal date following the 60-day administrative review of the application.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.”
About TLX250-CDx
TLX250-CDx (Zircaix®1) is an investigational PET agent that is under development for the diagnosis and characterisation of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers[5]. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterising ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.
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[1] Brand name subject to final regulatory approval.
[2] Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment.
[3] Positron emission tomography.
[4] Prescription Drug User Fee Act.
[5] Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022.22.
TLX250-CDx has not been granted marketing authorisation in any jurisdiction