Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its clear cell renal cell carcinoma PET radiotracer TLX250-CDx (Zircaix).
The PET tracer has been granted a rolling review process under the FDA’s Breakthrough Therapy designation, which will enable a progressive submission and review of required modules in a timeframe agreed upon with the FDA, the company said. It has also requested priority review.
In addition, Telix said it has opened an expanded access program in the U.S. and a named-patient program in Europe to allow access to Zircaix outside of clinical trials to patients for whom there are no comparable or satisfactory alternate options.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
