Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TLX250-CDx (Zircaix®), an investigational PET imaging agent for kidney cancer. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target date of August 27, 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), a highly aggressive form of kidney cancer.

Backed by strong Phase 3 ZIRCON study data published in The Lancet Oncology, TLX250-CDx demonstrated high diagnostic accuracy, positioning it as a potential game-changer in kidney cancer management. Telix CEO Kevin Richardson emphasized the company’s mission to revolutionize renal cancer diagnostics, likening its impact to PSMA-PET/CT in prostate cancer. With a commercial launch anticipated in 2025, the company aims to equip physicians with a powerful tool for more accurate and timely patient management.