The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.
The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.
TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.
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