Posted by Michael Wonder on 23 Mar 2025
FDA approves new prostate cancer imaging agent Gozellix
21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix (TLX007-CDx, kit for the preparation of gallium 68 (Ga 68) gozetotide injection), Telix's next generation PSMA PET imaging agent for prostate cancer.
Gozellix, after radiolabeling with Ga 68, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen level.
