FDA Grants Priority Review To Telix’s Kidney Cancer Imaging Agent

Telix announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for TLX250-CDx (Zircaix®,89Zr-DFO-girentuximab), an investigational PET imaging agent for kidney cancer. The FDA granted Priority Review and set a PDUFA date of August 27, 2025, positioning TLX250-CDx for a U.S. commercial launch next year.  

Kevin Richardson, Chief Executive Officer of Precision Medicine, said in a statement, “We are delighted that the FDA has accepted this BLA as it moves us one step closer to bringing our breakthrough product to patients. We are aiming to revolutionize the management of kidney cancer, just as PSMA-PET/CT scanning has changed the management of prostate cancer. By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix2 will help physicians make more timely and confident patient management decisions and more quickly provide patients with a clear understanding of their disease and treatment options. Building further on Telix’s successful urology franchise, we are preparing to bring this powerful precision medicine product to market in 2025.”

If approved, TLX250-CDx would become the first imaging agent capable of accurately and non-invasively diagnosing clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. It targets carbonic anhydrase IX (CAIX), a protein present in 95% of ccRCC cases, ensuring precise imaging. The BLA submission is backed by Telix’s global Phase 3 ZIRCON study, which reported strong diagnostic accuracy. The study’s findings, published in The Lancet Oncology, highlight the unmet need for improved renal cancer diagnostics and recognize TLX250-CDx as a potentially practice-changing innovation.