Posted by Michael Wonder on 18 Dec 2023
Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer
19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA for its investigational positron emission tomography imaging agent TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma.
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.
