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A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

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Trial Profile

A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Girentuximab Zr-89 (Primary)
  • Indications Renal cell carcinoma; Sarcoma
  • Focus Diagnostic use; Registrational
  • Acronyms ZIRCON
  • Sponsors Telix Pharmaceuticals

Most Recent Events

  • 26 Feb 2025 According to a Telix Pharmaceuticals media release, that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) 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 U.S. commercial launch in 2025.
  • 13 Jan 2025 According to a Telix Pharmaceuticals media release, company continues to target a U.S. commercial launch of TLX250-CDx (Zircaix, 89Zr- girentuximab) in H2 2025.
  • 29 Dec 2024 According to a Telix Pharmaceuticals media release, company submitted Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix, 89Zr- girentuximab) kidney cancer imaging. The FDA is expected to advise the PDUFA goal date following the 60-day administrative review of the application.

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