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History
- Received for publication June 17, 2022
- Revision received November 3, 2022
- Published online December 1, 2022.
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© 2022 by the Society of Nuclear Medicine and Molecular Imaging.
Author Information
- 1Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York; and
- 2Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
- Learning Objectives: On successful completion of this activity, participants should be able to (1) describe an overview of the FDA approval process, including data required for FDA application; (2) consider the difficulties and hurdles of FDA approval for therapies relating to prostate cancer and radiopharmaceuticals; and (3) recognize that despite these difficulties, recent FDA approval of radiopharmaceuticals in prostate cancer has occurred, specifically for 223Ra and 177Lu-PSMA-617.Financial Disclosure: Dr. Morris is a consultant paid less than $5,000 for the National Comprehensive Cancer Network and an investigator for accelerator applications for Johnson & Johnson and Novartis. This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at MSK and an NIH/NCI Cancer Center support grant to Memorial Sloan Kettering Cancer Center (P30 CA008748). Dr. Perera is sponsored by the Australian–American Fulbright Commission administered through a 2021–2022 Fulbright Future Scholarship funded by the Kinghorn Foundation. The authors of this article have indicated no other relevant relationships that could be perceived as a real or apparent conflict of interest.CME Credit: SNMMI is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing education for physicians. SNMMI designates each JNM continuing education article for a maximum of 2.0 AMA PRA Category 1 Credits. Physicians should claim only credit commensurate with the extent of their participation in the activity. For CE credit, SAM, and other credit types, participants can access this activity through the SNMMI website (http://www.snmmilearningcenter.org) through December 2025.
- For correspondence or reprints, contact Michael J. Morris (morrism{at}mskcc.org).
