Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (
68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging agent for prostate cancer. Gozellix®, after radiolabeling with
68Ga, 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 (PSA) level.
Read the full ASX release
here.