Posted by Michael Wonder on 16 Mar 2023
FDA approves expanded indication for Telix's Illuccix to include patient selection for PSMA directed radioligand therapy
16 March 2023 - Telix Pharmaceuticals today announces that the US FDA has approved a supplementary new drug application 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 US 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.
