Telix Pharma Submits BLA For TLX250-CDx Kidney Cancer Imaging To FDA

(RTTNews) - Telix Pharmaceuticals Limited (TLX) said that it has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for TLX250-CDx (Zircaix, 89Zr- girentuximab) kidney cancer imaging.

TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., the company said.

The FDA is expected to advise the PDUFA goal date following the 60-day administrative review of the application.

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