Production and regulatory issues for theranostics

Francesco Giammarile; Diana Paez; Richard Zimmermann; Cathy S Cutler; Amirreza Jalilian; Aruna Korde; Peter Knoll; Nayyereh Ayati; Jason S Lewis; Suzanne E Lapi; Roberto C Delgado Bolton; Jolanta Kunikowska; Enrique Estrada Lobato; Jean-Luc Urbain; Ola Holmberg; May Abdel-Wahab; Andrew M Scott

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

Production and regulatory issues for theranostics

Lancet Oncol. 2024 Jun;25(6):e260-e269. doi: 10.1016/S1470-2045(24)00041-X.

Authors

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: [email protected].

PMID: 38821100
PMCID: PMC11325260 (available on 2025-06-01)
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.

Publication types

Review

MeSH terms

Humans
Neoplasms / therapy
Precision Medicine
Radiopharmaceuticals* / therapeutic use
Theranostic Nanomedicine*

Substances

Radiopharmaceuticals

Abstract

Publication types

MeSH terms

Substances

Grants and funding