Telix Granted FDA Approval for ZIRCON Renal Cancer Imaging
Melbourne (Australia) – 23 January 2020. Telix Pharmaceuticals Limited is pleased to announce that the FDA has approved the ZIRCON study for American patients
Telix Pharmaceuticals Limited has today announced that the US Food and Drug Administration has approved the ZIRCON study for recruitment of American patients. The receipt of an Investigational New Drug (IND) notice of allowance will enable patient recruitment to commence in the United States in thirty (30) days.
The ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international Phase III study to evaluate the utility of TLX250-CDx (89Zr-girentuximab) for the imaging of clear cell renal cell cancer (ccRCC) using Positron Emission Tomography (PET). The study aims to recruit approximately 250 patients and is currently recruiting at 19 sites in Australia and Europe. The IND allowance in the US will add up to a further 6 leading cancer centres in the United States. The trial is expected to complete enrolment around mid-year.
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