FDA Grants Expanded Approval for Illuccix in Patient Selection for Pre-Taxane Radioligand Therapy

FDA Grants Expanded Approval for Illuccix in Patient Selection for Pre-Taxane Radioligand Therapy

The additional indication for the preparation kit of gallium Ga-68 gozetotide may facilitate earlier use of PSMA-targeted treatment for men with prostate cancer.

FDA expands Illuccix label to include patient selection for RLT in pre-taxane setting

The label expansion follows the FDA approval of an expanded label for 177Lu-PSMA-617 for use in patients with mCRPC after ARPI therapy and before chemotherapy.

Illuccix® Approved in U.S. for Patient Selection for Pre-Taxane RLT

Illuccix® Approved in U.S. for Patient Selection for Pre-Taxane RLT Melbourne (Australia) and Indianapolis (U.S.) | 23 June 2025 Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix…