Telix Pharmaceuticals Limited announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®, ⁸⁹Zr- girentuximab) kidney cancer imaging².

TLX250-CDx is an investigational PET drug product for the non-invasive diagnosis and characterization 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 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.”