Telix Pharmaceuticals submits BLA for kidney cancer imaging agent TLX250-CDx (Zircaix) based on Phase III ZIRCON study.
Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for its kidney cancer imaging agent, TLX250-CDx (Zircaix). The BLA is based on the successful Phase III ZIRCON study, which demonstrated high sensitivity and specificity for detecting clear cell renal cell carcinoma. If approved, TLX250-CDx will be the first targeted radiopharmaceutical imaging agent for kidney cancer in the U.S., expanding Telix's urology imaging franchise.
June 02, 2024
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