Telix Granted FDA Breakthrough Therapy Designation for Renal Cancer Imaging Product
Melbourne (Australia) – 1st July 2020. Telix announces that the FDA has granted Breakthrough Therapy (BT) designation for Telix’s renal cancer imaging product TLX250-CDx
Telix Pharmaceuticals Limited is pleased to announce that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy (BT) designation for Telix’s renal cancer imaging product TLX250-CDx (89Zr-girentuximab).
Under BT status, the FDA will work closely with Telix to provide guidance to the Company on the development of TLX250-CDx for the diagnosis of “indeterminate renal masses” that have been identified on CT or MRI imaging. TLX250-CDx is being developed for the purpose of determining whether such “indeterminate renal masses” are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging.
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