Telix Pharmaceuticals (ASX:TLX) has announced that the US FDA has accepted its Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix, 89ZrDFO-girentuximab).
The US regulator has granted Zircaix a priority review and provided a Prescription Drug User Fee Act date of 27 August 2025, paving the way for a US commercial launch in 2025.
Telix said that, 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.
Zircaix works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on 95 per cent of ccRCC cells, to produce images with a high tumour-to-background ratio and high intra- and inter-reader consistency.
Telix said the submission is based on its successful global Phase 3 ZIRCON study, which demonstrated a sensitivity of 86 per cent, specificity of 87 per cent and a positive predictive value of 93 per cent for ccRCC, including in very small, difficult-to-detect lesions.
Kevin Richardson, CEO of Telix's Precision Medicine division, said, “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 revolutionise the management of kidney cancer, just as PSMA-PET/CT7 scanning has changed the management of prostate cancer.
"By providing a more definitive clinical diagnosis for renal masses, we believe that Zircaix 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.”