This review outlines the regulatory approval process for radiopharmaceuticals, focusing on prostate cancer (PCa) as a case study. Radiopharmaceutical therapy is becoming increasingly important in cancer treatment due to its effectiveness in targeting metastatic disease.
The review covers the complex steps required for FDA approval, highlighting the challenges specific to radiopharmaceuticals. It details the successful approval processes of 223Ra-dichloride and 177Lu-PSMA-617, emphasizing the importance of rigorous trial design and adherence to regulatory frameworks.
The insights gained from these approvals provide a model for future development of radiopharmaceuticals in PCa and other cancers.
