Telix Pharmaceuticals Limited announced that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix?? 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). Under the Breakthrough Therapy designation, TLX250-CDx has been granted a rolling review process, which enables a progressive submission and review of required modules in a timetable pre-agreed with the FDA.

With the BLA submission, Telix has also requested Priority Review, which if granted would support an expedited review time.