Telix Receives the US FDA’s Breakthrough Therapy Designation for TLX250-CDx (89Zr-girentuximab)

Shots:

• The US FDA has granted BTD for Telix’s renal cancer imaging product TLX250-CDx (89Zr-girentuximab)
• Under BTD, the FDA will work closely with Telix to provide guidance 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 “indeterminate renal masses” are either ccRCC or non-ccRCC, using PET imaging

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