Core Viewpoint - Telix Pharmaceuticals has announced the commercial availability of its next-generation PSMA-PET imaging agent, Gozellix, for prostate cancer in the United States, enhancing diagnostic capabilities and patient access [1][4][7]. Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in multiple countries including the U.S., Brazil, Canada, Europe, and Japan [8]. Product Details - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, providing early and accurate detection of metastases with a specificity of 90% and capable of detecting micrometastases at PSA levels as low as 0.02 ng/mL [3][4]. - The product features an extended "hot" shelf-life of up to six hours, improving patient access and convenience by allowing greater transportation distances and clinical administration windows [5]. - Gozellix can be produced centrally or locally, offering flexibility in production and on-demand capacity, supported by the ARTMS QUANTM Irradiation System [6][10]. Market Context - PSMA-PET imaging has become the standard of care for staging and identifying biochemical recurrence of prostate cancer, yet only a small fraction of the 3.4 million men with prostate cancer in the U.S. have utilized this technology due to access challenges [4][5]. - Telix has applied for reimbursement for Gozellix for Medicare-eligible patients in the hospital outpatient setting, aiming to enhance accessibility [4][24].
Telix Launches New Prostate Cancer Imaging Agent, Gozellix, in U.S.