Abstract

Radiopharmaceutical targeted therapy (RPT) has been studied for decades; however, recent clinical trials demonstrating efficacy have helped renewed interest in the modality. This article reviews National Cancer Institute (NCI)'s support of RPT through communication via workshops and interest groups, through funding extramural programs in academia and small business, and through intramural research, including preclinical and clinical studies. NCI has co-organized workshops and organized interest groups on RPT and RPT dosimetry to encourage the community and facilitate rigorous preclinical and clinical studies. NCI has been supporting RPT research through various mechanisms. Research has been funded through peer-reviewed NCI Research and Program Grants (RPG) and NCI Small Business Innovation Research (SBIR) Development Center, which funds small business-initiated projects, some of which have led to clinical trials. The NCI Cancer Therapy Evaluation Program (CTEP)'s Radiopharmaceutical Development Initiative supports RPT in NCI-funded clinical trials, including Imaging and Radiation Oncology Core (IROC) expertise in imaging QA and dosimetry procedures. Preclinical targeted a-emitter therapy (TAT) research at the NCI's intramural program is ongoing, building on foundational work dating back to the 1980s. Ongoing "bench-to-bedside" efforts leverage the unique infrastructure of the National Institutes of Health's (NIH) Clinical Center. Given the great potential of RPT, our goal is to continue to encourage its development that will generate the high-quality evidence needed to bring this multidisciplinary treatment to patients.

Highlights

  • The United States National Cancer Institute’s (NCI) mission is to lead, conduct, and support cancer research across the nation

  • In the early 2000s, the United States Food and Drug Administration (FDA) approved two new radiopharmaceutical targeted therapy (RPT) antibodies directed against the CD-20 B-cell antigen expressed on the surface of non-Hodgkin lymphoma cells, 90Y-ibritumomab tiuxetan, (Zevalin [2002]; Spectrum Pharmaceuticals, Inc.) and 131I-tositumomab (Bexxar [2003]; GlaxoSmithKline) [2,3,4]

  • The NCI brought together experts in the fields of nuclear medicine, radiation oncology, and medical physics for a workshop in 2018 to address issues and strategies of dosimetry for future clinical trials [11]. This meeting resulted in several publications [15,16,17] and creation of the NCI Imaging and Radiation Oncology Core (IROC) Focus Group to provide support for RPT dosimetry methodology and expertise for principal investigators of NCI-funded RPT clinical trials

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Summary

Norman Coleman National Cancer Institute

Keywords: Radiopharmaceutical targeted therapy, targeted alpha-emitter therapy, National Cancer Institute License: This work is licensed under a Creative Commons Attribution 4.0 International License. Version of Record: A version of this preprint was published at European Journal of Nuclear Medicine and Molecular Imaging on August 11th, 2021. See the published version at https://doi.org/10.1007/s00259021-05503-z.

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