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.
