Telix Pharmaceuticals has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its new PET agent, TLX250-CDx.
TLX250-CDx (Zircaix) characterizes renal masses as clear cell renal cell carcinoma, the company said. It initiated the BLA submission in December 2023, basing it on its phase III ZIRCON study, which showed the agent to have a sensitivity of 86%, a specificity of 87%, and a positive predictive value (PPV) of 93% for clear cell renal cell carcinoma.
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