Australian biopharmaceutical company Telix Pharmaceuticals Limited (ASX:TLX) (Nasdaq:TLX) announced on Wednesday that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab).

The application was granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) date of 27 August 2025. The imaging agent is expected to be launched commercially in 2025.

If approved, Zircaix will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterise clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer.

The BLA is based on the company's successful global Phase 3 ZIRCON study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions.

Results of this study were published in The Lancet Oncology in September 2024.