The clearance covers use of Illuccix for staging and restaging intermediate and high-risk prostate cancer and localizing tumor tissue in recurrent disease. Illuccix is used for PET imaging of specific membrane antigen (PSMA) positive lesions in men with prostate cancer who have suspected metastasis and are eligible for initial definitive therapy, as well as those with suspected disease recurrence with elevated serum PSA levels.

Telix's distribution partner, Isologic Innovative Radiopharmaceuticals (ISOLOGIC), will market the agent in Canada, the company said.