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Telix Pharmaceuticals Announces US FDA Expanded Indication for Illuccix®

Friday, March 17, 2023

Telix Pharmaceuticals announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.

Use of Illuccix in the VISION Phase III study helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy.

The label expansion indicates that Illuccix is now approved in the U.S. to select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)- directed radioligand therapy (Pluvicto®), providing doctors with critical information to help optimise and guide treatment decisions. As the only diagnostic agent for suspected metastatic and recurrent 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.

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