Production and regulatory issues for theranostics

Francesco Giammarile¹, Diana Paez¹, Richard Zimmermann², Cathy S Cutler³, Amirreza Jalilian⁴, Aruna Korde⁴, Peter Knoll⁴, Nayyereh Ayati⁵, Jason S Lewis⁶, Suzanne E Lapi⁷, Roberto C Delgado Bolton⁸, Jolanta Kunikowska⁹, Enrique Estrada Lobato¹, Jean-Luc Urbain¹⁰, Ola Holmberg¹¹, May Abdel-Wahab¹, Andrew M Scott¹²

Affiliations

¹ Division of Human Health, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
² Chrysalium Consulting, Lalaye, France; MEDraysintell, Louvain la Neuve, Belgium; Oncidium Foundation, Auderghem, Belgium.
³ Isotope Research and Production Department, Brookhaven National Laboratory Upton, New York City, NY, USA.
⁴ Division of Physical and Chemical Sciences, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
⁵ Centre for Health Economics, Monash Business School, Monash University, Melbourne, VIC, Australia.
⁶ Department of Radiology and Program in Molecular Pharmacology, Memorial Sloan Kettering Cancer Center, Upton, NY, USA; Departments of Radiology and Pharmacology, Weill Cornell Medical College, New York City, NY, USA.
⁷ Departments of Radiology and Chemistry, O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
⁸ Department of Diagnostic Imaging (Radiology) and Nuclear Medicine, University Hospital San Pedro and Centre for Biomedical Research of La Rioja, Logroño, Spain; Servico Cántabro de Salud, Santander, Spain.
⁹ Nuclear Medicine Department, Medical University of Warsaw, Warsaw, Poland.
¹⁰ Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
¹¹ Department of Nuclear Science and Applications, and Division of Radiation, Transport and Waste Safety, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
¹² Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia; Department of Molecular Imaging and Therapy, Olivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia. Electronic address: andrew.scott@onjcri.org.au.

PMID: 38821100
PMCID: PMC11325260
DOI: 10.1016/S1470-2045(24)00041-X

Review

Production and regulatory issues for theranostics

Francesco Giammarile et al. Lancet Oncol. 2024 Jun.

. 2024 Jun;25(6):e260-e269.

doi: 10.1016/S1470-2045(24)00041-X.

Authors

Affiliations

¹ Division of Human Health, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
² Chrysalium Consulting, Lalaye, France; MEDraysintell, Louvain la Neuve, Belgium; Oncidium Foundation, Auderghem, Belgium.
³ Isotope Research and Production Department, Brookhaven National Laboratory Upton, New York City, NY, USA.
⁴ Division of Physical and Chemical Sciences, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
⁵ Centre for Health Economics, Monash Business School, Monash University, Melbourne, VIC, Australia.
⁶ Department of Radiology and Program in Molecular Pharmacology, Memorial Sloan Kettering Cancer Center, Upton, NY, USA; Departments of Radiology and Pharmacology, Weill Cornell Medical College, New York City, NY, USA.
⁷ Departments of Radiology and Chemistry, O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
⁸ Department of Diagnostic Imaging (Radiology) and Nuclear Medicine, University Hospital San Pedro and Centre for Biomedical Research of La Rioja, Logroño, Spain; Servico Cántabro de Salud, Santander, Spain.
⁹ Nuclear Medicine Department, Medical University of Warsaw, Warsaw, Poland.
¹⁰ Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
¹¹ Department of Nuclear Science and Applications, and Division of Radiation, Transport and Waste Safety, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
¹² Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia; Department of Molecular Imaging and Therapy, Olivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia. Electronic address: andrew.scott@onjcri.org.au.

PMID: 38821100
PMCID: PMC11325260
DOI: 10.1016/S1470-2045(24)00041-X

Abstract

Theranostics has become a major area of innovation and progress in cancer care over the last decade. In view of the introduction of approved therapeutics in neuroendocrine tumours and prostate cancer in the last 10 years, the ability to provide access to these treatments has emerged as a key factor in ensuring global benefits from this cancer therapy approach. In this Series paper we explore the issues that affect access to and availability of theranostic radiopharmaceuticals, including supply and regulatory issues that might affect the availability of theranostic treatments for patients with cancer.

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Conflict of interest statement

Declaration of interests RZ reports direct relations with Global Morpho Pharma, Posifit–Nancyclotep, LemerPax, MEDraysintell, Chrysalium Consulting, and Telix Pharma. NA reports having received a travel grant from the Australian and New Zealand Society of Nuclear Medicine. JSL reports research support from Clarity Pharmaceuticals and AVID Radiopharmaceuticals; has acted as an adviser of Boxer, Clarity Pharmaceuticals, Curie Therapeutics, Earli, Evergreen Theragnostics, NexTech Invest, Telix Pharmaceuticals, Suba Therapeutics, inhibrx, Precirix, Alpha-9 Oncology, and TPG Capital; is a co-inventor on technologies licensed to Diaprost, Elucida Oncology, Theragnostics, CheMatech, and Samus Therapeutics; is the co-founder of pHLIP; holds equity in Summit Biomedical Imaging, Telix Pharmaceuticals, and Evergreen Theragnostics; and is supported by National Institutes of Health R35 CA232130. SEL reports research support from Navidea Biopharmaceuticals, Fusion Pharmaceuticals, Cytosite Biopharma, Viewpoint Molecular Targeting, and Genzyme Corporation; has acted as an adviser for NorthStar Medical Radioisotopes and Trevarx biomedical; and is supported by the US Department of Energy as part of the DOE University Isotope Network under grant DESC0021269. JK reports participation on a data safety monitoring board and advisory board for Novartis (personal fees), and an unrestricted grant from Janssen. AMS reports trial funding from EMD Serono, ITM, Telix Pharmaceuticals, AVID Radiopharmaceuticals, Fusion Pharmaceuticals, and Cyclotek; research funding from Medimmune, AVID Radiopharmaceuticals, Adalta, Antengene, Humanigen, Telix Pharmaceuticals, and Theramyc; is a co-inventor on technologies licensed to Humanigen, AbbVie and Life Science Pharmaceuticals; participates on the advisory boards of Imagion and ImmunOs; and is supported by an Australian National Health and Medical Research Council grant number 1177837. CSC is supported by the US Department of Energy under grants Lab 20-2301, DE-FOA-0003063, and DE-FOA-0002532. All other authors declare no competing interests.

Figures

**Figure 1.**
World map showing the distribution of research reactors used in the production of radionuclides. Large capacity reactors for radionuclide production are in Europe (Belgium, Netherlands), Australia and South Africa.

**Figure 2.**
World map showing the worldwide distribution of cyclotrons used in the production of radionuclides.

See this image and copyright information in PMC

References

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1. Baum RP, Kulkarni HR. THERANOSTICS: From Molecular Imaging Using Ga-68 Labeled Tracers and PET/CT to Personalized Radionuclide Therapy - The Bad Berka Experience. Theranostics. 2012;2:437–47. doi: 10.7150/thno.3645. - DOI - PMC - PubMed

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Production and regulatory issues for theranostics

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Production and regulatory issues for theranostics

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Conflict of interest statement

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