Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®), a diagnostic agent for kidney cancer. This investigational PET imaging product is designed to assist in the non-invasive diagnosis and assessment of clear cell renal cell carcinoma (ccRCC), the most common and aggressive type of kidney cancer.

If approved, TLX250-CDx will become the first targeted PET imaging agent for kidney cancer available in the United States, enhancing Telix's presence in the field of urology imaging. Following the FDA's 60-day administrative review of the application, the agency will confirm the Prescription Drug User Fee Act (PDUFA) target date.

TLX250-CDx has been granted Breakthrough Therapy designation by the FDA, potentially allowing for priority review. Telix aims to commence a full commercial launch in the United States in 2025, addressing a significant unmet need for improved diagnostic options in suspected ccRCC cases.

About TLX250-CDx

TLX250-CDx (Zircaix®) is a PET imaging agent under development to aid in the diagnosis and characterization of ccRCC. Results from the pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) demonstrated the agent’s effectiveness in detecting ccRCC. Among the 284 evaluable patients, the trial met all primary and secondary endpoints, showing 86% sensitivity, 87% specificity, and a 93% positive predictive value for ccRCC. These findings were confirmed by three independent radiology readers, indicating a high level of accuracy and consistency in identifying the clear cell phenotype.

Telix believes the data highlights TLX250-CDx as a reliable and non-invasive diagnostic option for ccRCC, offering significant clinical value.

 

 

Source: telixpharma.com

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