FDA-Approved Radiopharmaceuticals in Oncologic PET Imaging: Current Status and Clinical Impact

Cancer persists as a formidable adversary to human health, with its early-stage detection posing a persistent and intricate challenge. While radiologic imaging serves as a cornerstone in the diagnostic arsenal for oncological conditions, the incipient manifestations of malignancies frequently present with such subtlety that they elude recognition, resulting in missed opportunities for timely and potentially life-saving interventions. Several radiodiagnostic agents have received regulatory approval from the US FDA for clinical application in the oncological domain, specifically to facilitate the detection, localization, and characterization of malignant neoplasms through advanced imaging techniques. With the FDA approvals of [18F]F-rhPSMA-7.3, [18F]F-piflufolastat, [68Ga]Ga-PSMA-11, [18F]F-fluoroestradiol, and [64Cu]Cu-dotatate into clinical oncology practice, marking the beginning of a new era in cancer care. This manuscript provides a comprehensive overview of a 5-year review of FDA-approved diagnostic radiopharmaceuticals in oncology, highlighting the clinical studies that supported their approval and additional clinical trials evaluating their use in PET imaging.