RT Journal Article
SR Electronic
T1 From Concept to Regulatory Drug Approval: Lessons for Theranostics
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 1793
OP 1801
DO 10.2967/jnumed.121.263301
VO 63
IS 12
A1 Marlon Perera
A1 Michael J. Morris
YR 2022
UL http://jnm.snmjournals.org/content/63/12/1793.abstract
AB Radiopharmaceutical therapy is an emerging treatment modality that has demonstrated increasing importance as a significant component in the treatment of cancer. Prostate cancer (PCa) remains one of the commonest solid-organ tumors and is associated with significant societal burdens. Despite significant disease heterogeneity, PCa remains an ideal candidate for radiopharmaceutical therapy because of the prolonged disease course, metastatic disease tropism, and sensitivity to radiation therapy. To date, advanced PCa remains one of the most successful arenas for the development and approval of radiopharmaceutical agents. In this review, we aim to summarize the complex processes required to obtain regulatory approval for a novel agent and highlight the limitations and hurdles specific to the approval of radiopharmaceutical agents. In advanced PCa, we outline the importance of a framework for trial design with respect to defining disease state and acceptable outcome measures—as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG). Finally, using the principles mandated by the Food and Drug Administration approval process and the framework provided by the PCWG, we outline experience with the successful approval of the radiopharmaceutical agents 223Ra and 177Lu-PSMA-617.