FDA approves expanded Use of Telix’s Illuccix for PSMA-Directed Radioligand Therapy

Mar 16, 2023

Telix Pharmaceuticals Ltd (ASX: TLX) has received regulatory approval from the US Food and Drug Administration (FDA) to expand the indication of its diagnostic agent Illuccix. The approval allows the use of the gallium Ga 68 gozetotide injection kit to select patients with metastatic prostate cancer who may benefit from lutetium-177 PSMA-directed therapy. Illuccix is now the only diagnostic agent for prostate cancer that combines the accuracy of gallium imaging with the reliability and flexibility of Telix's distribution network.

The expanded indication for Illuccix has the potential to improve access to imaging for patients who are candidates for radioligand therapy. The expanded indication will provide doctors with critical information to guide patient management and optimize treatment outcomes. The VISION Phase III study showed that the use of Illuccix helped doctors detect prostate cancer and identify appropriate patients for PSMA-based radioligand therapy.

 

 

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