Posted by Michael Wonder on 27 Feb 2025
FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review
26 February 2025 - Telix today announces that the US FDA has accepted the biologics license application for its breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granted a priority review and provided a PDUFA date of 27 August 2025, paving the way for a US commercial launch in 2025.
The biologics license application is based on Telix’s successful global Phase 3 ZIRCON study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value of 93% for ccRCC, including in very small, difficult to detect lesions.
