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Updated: Jun 25, 2025
Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
Published on: October 4, 2024
Production and regulatory issues for theranostics
Francesco Giammarile1, Diana Paez1, Richard Zimmermann2
1Division of Human Health, Department of Nuclear Safety and Security, International Atomic Energy Agency, Vienna, Austria.
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.
Insights
Theranostics, a key cancer therapy, faces access challenges globally. This paper examines supply and regulatory hurdles impacting the availability of radiopharmaceuticals for patients with neuroendocrine tumors and prostate cancer.
Area of Science:
- Oncology
- Nuclear Medicine
- Radiopharmaceutical Therapy
Background:
- Theranostics has significantly advanced cancer care in the past decade.
- Approved theranostic agents are now available for neuroendocrine tumors and prostate cancer.
- Global access to these innovative treatments is crucial for patient benefit.
Purpose of the Study:
- To explore factors affecting the accessibility and availability of theranostic radiopharmaceuticals.
- To identify supply chain and regulatory challenges impacting theranostic treatment delivery.
- To ensure equitable global access to advanced cancer therapies.
Main Methods:
- Review of current literature on theranostic radiopharmaceutical supply chains.
- Analysis of regulatory landscapes impacting radiopharmaceutical approval and distribution.
- Case study examination of access issues in different global regions.
Main Results:
- Significant disparities exist in global access to theranostic radiopharmaceuticals.
- Supply chain complexities and manufacturing limitations hinder widespread availability.
- Varying national regulatory frameworks create barriers to treatment adoption.
Conclusions:
- Addressing supply and regulatory challenges is essential for expanding theranostic benefits.
- International collaboration is needed to harmonize regulations and improve supply chains.
- Ensuring global access to theranostic radiopharmaceuticals is critical for equitable cancer care.
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