FDA approves expanded indication for Illuccix to include patient selection for PSMA-directed radioligand therapy for prostate cancer.- Telix Pharma
Telix Pharmaceuticals announces that the 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.
The label expansion means 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 optimize and guide treatment decisions. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.
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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